The Kentucky Pharmacist (March/April 2019)

Vol. 14 No. 2 March/April 2019

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

INSIDE:  

Board of Directors Ballot Save the Date KPhA Annual Meeting & Convention—June 20—23 Marriott Griffin Gate Resort & Spa Lexington

TABLE OF CONTENTS FEATURES Kentucky Pharmacist Day at the Capitol Recap |8| KPhA Board of Directors Ballot |10| Summer Camps for Children with Medical Conditions: A ServiceLearning Opportunity for Students, Residents and Pharmacists |39|

Mission Statement: The mission of KPhA is to advocate for and advance the profession through an engaged membership.

On the Cover Photos provided by the Lexington CVB and Marriott Griffin Gate Resort & Spa

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Editorial Office: ©Copyright 2019 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.

Publisher: Mark Glasper Managing Editor: Sarah Franklin Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601.

Phone: 502.227.2303 Fax: 502.227.2258.

Email: info@kphanet.org.

Website: www.kphanet.org.

IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |6| Advocacy Matters |13| Continuing Pharmacy Education |14| Continuing Pharmacy Education Quiz—March |19| Answer Sheet—Jan |21| Continuing Pharmacy Education |24| Continuing Pharmacy Education Quiz—April|30| Answer Sheet—Feb |31| New KPhA Members | 33| Pharmacy Policy Issues | 34| Pharmacy Law Brief | 36| Campus Corner |37|

ADVERTISERS APSC|5| PTCB |23| EPIC |33| Pharmacists Mutual |42| Cardinal |43| APMS |Back cover|

|2| Kentucky Pharmacists Association | March/April 2019

PRESIDENT’S PERSPECTIVE I am writing this article as we are in the midst of the 2019 legislative session. Just for some background information, the Kentucky legislature convenes in regular session for 60 days in even-numbered years and for 30 days in odd-numbered years. It may also convene in special sessions at the call of the governor. As you can see, this year’s session is a short session. Meaning there are only 30 legislative days where bills can be voted on by both chambers to ultimately be presented to the governor to be signed into law. As you might have guessed, a short session makes passing legislation a bit more difficult, especially if the legislation is complex and will be challenged by groups not agreeing with the proposed legislation. Some say, you should not even try to pass controversial, large or complex legislation and instead utilize the short session to make small changes to already existing laws, otherwise known as clean-up bills.

“We can no longer get by with passing simple bills that are easy for the PBMs to circumvent.”

As you may recall in my January/February President Perspective article, I explained that one of our goals of this legislative session was to pass new legislation that will level the playing field between the goliath companies known as PBMs and all pharmacies from independent, to chain and outpatient hospital. Our KPhA’s Government Affairs Committee has worked extremely hard to develop a comprehensive PBM bill we have come to refer as the kitchen sink bill. This is the first time since I joined the KPhA Board of Directors that we have attempted to pass such a large and comprehensive piece of legislation. The bill known as SB 139 is sponsored by Senator Jimmy Higdon and has 5 co-sponsors. We were making great progress in a short amount of time. But then the competing lobbyists from the PBMs and health care plans came into town. Remember in my opening paragraph, I describe there are instances where certain legislation is difficult to pass in a short session. Well, our PBM bill has proven to be such a piece of legislation. In my opinion, we had to make a valiant effort this session for a few reasons. First, as you all know there is plenty of heat on the PBMs. They have been making

headlines as of late so the thought was to strike while the iron is hot. Secondly, retail pharmacies, chain and hospital outpatient included, are struggling now more than ever due to nonsensical fees, etc. imposed by the PBMs.

Chris Palutis As I write this article, I adPresident, KPhA mittedly do not know the final outcome of our comprehensive PBM bill SB 139.

And you may be asking yourself, “Why is he writing about this, especially since it may not pass?” Well, let me explain.

At the onset of our planning session for this year’s legislative efforts, we knew attempting to pass this comprehensive PBM legislation would be extremely difficult.

While we hoped and worked hard for the best, we prepared for the worst. We may not get our complete bill passed, but we have already accomplished a lot. First, we have put the PBMs on notice that here in Kentucky, we are not going to simply sit idly by while they exploit our pharmacists for their own financial gain. Secondly, we have been communicating with the legislators and they now know that in order for them to help us reign in the PBMs, a comprehensive piece of legislation is required. We can no longer get by with passing simple bills that are easy for the PBMs to circumvent. Lastly, we have gained an invaluable amount of knowledge about what we need to do in next year’s twice-as-long legislative session in order to get our comprehensive PBM legislation passed should SB 139 not pass in this session. The team that has worked very hard this year has already committed to working even harder beginning this April/May to draft an even better version of our bill. In addition, we will have plenty of time to meet with all the necessary folks such as the Department of Insurance, Department of Medicaid, Cabinet for Health and Family Services, and of course the legislators themselves. If anyone reading this article would like to be part of the process, please reach out to me. The more of our very intelligent and passionate members we have involved, the better off we are as an association.

Continued on pg. 4 |3| www.KPHANET.org

President’s Perspective Cont.

As you know, it is hard work to champion the passage of new legislation, especially when it appears to be a David and Goliath type battle. But we will not stop until we are successful. I willingly accept the challenge to continue the fight on your behalf. The PBMs think they can wear us down and ultimately win, but they are wrong.

I want to close this article by asking for your continued support when called upon and also to give a big THANKS to all of you who reached out to your legislators in support of this bill. Please know that this year we have had a record number of letters and phone calls placed to the legislators in Frankfort, and it is all because of how much each and every one of you cares about our great profession. Thank you again and know the fight is not over. We must continue on and endure through

next year’s session but cannot do it without all of your dedication and continued support.

Save the Date!

KPhA Legislative Conference November 1–2, 2019 Griffin Gate Marriott Resort & Spa

Member Spotlight Tanner Hobbs is a first year new practitioner working as a pharmacy manager in a retail pharmacy.

He joined KPhA to network with fellow pharmacists and to maintain updated knowledge surrounding the ever-changing healthcare issues. Growing up, Tanner had always been interested in healthcare, mainly the clinical and financial/business aspects. He was able to combine these interests by completing a PharmD/MBA degree. From there, he solidified his decision to pursue pharmacy.

Tanner loves that pharmacy presents the opportunity to serve as the pivotal bridge between providers and medication on patients’ behalf. It is a privilege that in whatever position he is able to create a positive outcome. While Tanner has learned many lessons from the pharmacy industry the main lesson is that the industry is complex, with many different paths and levels of medication access that the general public doesn’t realize. He states, “It is our job as pharmacists acting at any level to ensure that the patient receives the best medication option in the most efficient manner possible to improve their health and well-being.” The most important advice Tanner would give to future pharmacists is to pursue the avenue of pharmacy you have the genuine interest in. “When you combine talented minds with genuine passion it can result in beautiful outcomes.”

Wednesday, April 17, 2019 | 7:00 - 9:30 PM | Le Moo (Louisville) | 2300 Lexington Rd, Louisville, KY 40206 Sponsored by Novo Nordisk Free Networking Event Schedule •

6:30-7:00 p.m.

Registration Open

•

7:00-7:30 p.m.

Educational Presentation by Novo Nordisk (non-CEU)

•

7:30-9:30 p.m.

Networking Event

Heavy hors d’oeuvres and wine/beer will be available (self-pay for liquor drinks). |4| Kentucky Pharmacists Association | March/April 2019

|5| www.KPHANET.org

MY KPhA Rx KPhA Headquarters Building to Transfer Ownership We want to thank these incredibly generous donors who are listed below.

Clark Kebodeaux Michael & Lee Ann Keller Chris Killmeier Kentucky Renaissance Pharmacy Museum $50,000+ Wayne Morris J Leon & Margaret Claywell Chris & Consuelo Palutis $25,000-49,999 Donnie Riley C Michael Davenport Richard Ross Sam Willett Kelly Smith Michael & Mary Ann Wyant Leah Tolliver $20,000-24,999 Lewis & Kim Wilkerson

By Mark Glasper Robert Goforth $1—999 $10,000-19,999 KPhA Executive Lanny Branstetter Jeff Arnold Director/CEO Angela Brunemann George & Burnetta Hammons Cardinal Health Matching Gift You may recall roughly two years Jefferson Co. Academy of PharProgram macists ago that KPhA moved its headMargaret Christopher Duane Parsons Chad Corum quarters to its current location at Richard & Zena Slone James & Debra Dunaway 96 C Michael Davenport Blvd. in $5,000-9,999 William R. Brown-Gibson’s Phar- Ashley Eschenbach Frankfort. The move was arBrian Fingerson macy ranged to have the Kentucky William R. Brown-Medical Arts Andrew & Virginia France Pharmacy Education & Research Pharmacy Thomas Roe Frazer Angela Gibson Foundation (KPERF) purchase Fred Carrico Josiah Jaggers the building and then lease it back Matt Carrico Claire Love Marshall Davis to KPhA for tax purposes.

Elizabeth Ramey Matt Foltz Melody Ryan At the same time, we launched a Tim Ford William Shely Capital Building Campaign to so- Don & Vicki Kupper Jo Anne Taheri Phil & Julie Losch licit donations to help pay for the Joe Mashni Robert & Jason Wallace Jacob & Carol Wishnia new headquarters building. It William “Pat” Mattingly was very important for these do- Bob Oakley $1,000-4,999 nations to go to KPERF, the Goals & Needs Change Ray Bishop building owner, so the donations Jessika Chilton-Chinn Time has passed and our fundcould be tax deductible. KPhA raising needs have changed. In Bob & Kim Croley Paul Easley members donated funds not only just two years, we’ve been able to Joseph L. Fink III to help purchase the building but accomplish our original goals to Trish Freeman also to make improvements to it. Cynthia Gray provide: Kelsey L. Hall Cathy Hance Chris Harlow |6| Kentucky Pharmacists Association | March/April 2019

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The space and technology for continuing education and pro-

fessional development training. 

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Mission To provide an environment for: the leverage of A place for pharmacists to network and learn community resources to expand preventive serfrom each other. vices, the development of pharmacists to advance The ability to greater unify the profession by practice, and the promotion of success stories of bringing together multiple stakeholders in public pharmacist guided wellness. health.

To see what they have planned for the Center for A setting to help the Association and our memExcellence, plan to attend the KPhA Annual Meetbers identify and explore opportunities to ading & Convention June 21-23, 2019 at the Marriott vance the role of pharmacy and make full use of Griffin Gate in Lexington, KY. We will celebrate our licenses through new centers of excellence. the conclusion of the Capital Building Campaign More visibility in the healthcare arena by our and thank donors while launching a bold, new location in the doctors’ office park. fundraising campaign for the Center for Excellence.

A more conducive atmosphere for productive committee and board work as well as allow for growth.

Outstanding Pledges Have Options With the transfer of the building June 1, 2019 from KPERF to KPhA, donors who have outstanding And, it’s the fourth goal above that leads us into the pledges to the Capital Building Campaign can still make their donations go to the building. Just make future and our new fundraising needs. your donation to KPERF by May 31, 2019. Or, Center for Excellence donors can direct their pledges to the new Center President Chris Palutis used tremendous foresight for Excellence fundraising campaign starting at the to appoint the new Center for Excellence ad hoc KPhA Annual Meeting in June.

Committee to look at the next stage of our fundraising needs and to develop goals that will help us stretch our imaginations for what is possible if we work together.

Center for Excellence Committee Chair Kim Croley and her committee are busily meeting to develop a Strategic Plan for the Center for Excellence.

We shouldn’t think of it as a physical, brick and mortar structure rather, a program or programs that will emanate from KPhA headquarters and take pharmacy to higher levels in Kentucky.

I don’t want to steal the committee’s thunder but here’s just a taste of their thinking process:

jobs.kphanet.org THE location for pharmacy job seekers + employers for targeted positions

Vision Improved wellness for the citizens of the Commonwealth through pharmacist guided care.

|7| www.KPHANET.org

Pharmacists Day at the Capitol Recap We are proud to say we had 73 attendees for Kentucky Pharmacists Day at the Capitol on February 28. including 32 pharmacists, 40 students and one pharmacy technician. The day began with a welcome from “Pharmacy Caucus� members (Rep. Danny Bentley, Rep. Robert Goforth, Rep. Steve Sheldon, Rep. Derek Lewis and Rep. Adam Bowling), Sen. Ralph Alvarado and Sen. Jimmy Higdon. We also recognized Sen. Alvarado and Rep. Jim DuPlessis with the 2018 Friend of Pharmacy award. KPhA lobbyist Shannon Stiglitz shared insights about how to advocate to prepare the attendees for their scheduled legislator visits.

Thank you to all those who attended - it is crucial for our unified voice to be heard in Frankfort!

Senators 9: Ralph Alvarado Ernie Harris Jimmy Higdon Paul Hornback Christian McDaniel Albert Robinson Will Schroder Dan Seum Brandon Smith

Pictured L-R Hanna Brown, Rep. Jerry Miller, Chris Betz, Marceline Aengwanama.

We hosted 26 legislators for lunch and had a great showing of support!

Representatives 17: Danny Bentley Charles Booker Adam Bowling Terri Clark Jim Duplessis Joseph Fischer Robert Goforth Mark Hart

KPhA Executive Director Mark Glasper presents Sen. Ralph Alvarado and Rep. Jim DuPlessis with he 2018 Friend of Pharmacy award.

Joni Jenkins Nima Kulkarni Derek Lewis* Mary Lou Marzian Patti Minter Melinda Prunty Dean Schamore Steve Sheldon Wilson Stone Attendees don their white coats in the Capitol Rotunda.

|8| Kentucky Pharmacists Association | March/April 2019

Pictured L-R Matt Carrico, Rep. Cluster Howard, Candace McQueen and KPhA President Chris Palutis.

KPhA member Kyle Harris meets with Rep. Tommy Turner.

KPhA member Ron Poole with Rep. Melinda Gibbons Prunty.

Sen. Jimmy Higdon addresses the attendees.

KPhA members L-R J Leon Claywell, Rep. Danny Bentley, KPhA President Chris Palutis and Rep. Steve Sheldon.

Rep. Robert Goforth speaks with the attendees.

KPhA member Ron Poole with Sen. CB Embry.

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KPhA Board of Directors Ballot The election ballot is now available for the KPhA Director 2019 - 2020 Board of Directors. All ballots must be received by May 4 and you must be logged in to vote. If you require a paper ballot, please contact us at 502.227.2303 or info@kphanet.org.

The following positions are up for election:

Cathy Hanna

My interest in serving on the KPhA Board of Directors stems from my long-standing interest in advancing the practice of pharmacy and promoting the role of pharmacists as President-Elect an integrated member of the healthcare team. While I have had Treasurer the privilege of working to advance these goals Director (3) through multiple venues, including my work as Vice President of Professional Affairs for the AmerPresident-Elect ican Pharmacy Services Corporation (APSC) and Joel C. Thornbury my recent service to the Kentucky Board of PharThis Association has been a valuable macy, I believe KPhA is key to our success, and as such, am eager to serve on the KPhA Board. part of my professional & personal life for over 2 decades now. I am I graduated from the University of Kentucky with a called to serve our profession and As- BS in AG Economics in 1983 and earned a BS in sociation in many manners. I ask for Pharmacy in 1986. After graduating from pharmacy your support again, wishing to lead school, I owned and managed an independent longour Association as we continue to push our profes- term care pharmacy for many years, returning to sion forward for all pharmacists.

UK to complete my PharmD degree in 2004. In my present role at APSC, I work with community I have been a career-long member of the Associapharmacists on policy, compliance, regulatory and tion serving & chairing many committees. I have operational issues. I also develop, educate and asbeen on and off the Board as an active member. I sist pharmacists with the implementation of emergpresently am on the Organizational Affairs Coming professional services. mittee and the Board of Directors.

I am passionate about pharmacy and continue to be Treasurer an advocate for the profession. I am a longChris Killmeier standing member of KPhA and an active member of the Advancing Pharmacy Practice in Kentucky I have been a pharmacist for 29 years Coalition (APPKC). I have developed and presentwith Walgreens. Within Walgreens I ed numerous continuing education programs to ashave held positions from staff pharsist pharmacists in meeting regulatory and accredimacist up to district pharmacy supertation standards, and to advance clinical pharmacy visor. I am currently pharmacy manpractice in a variety of practice settings. Most reager at Walgreens, 2420 Lime Kiln cently, I have worked with the Board of Pharmacy Lane, Louisville, KY 40222. I have to secure new authority for protocol-driven care and been on the Board of Directors for KPhA since the APPKC to prepare pharmacists to implement 2013. I have served as Chairman on the Advisory these new Board-authorized protocols.

Council to the Kentucky Board of Pharmacy for eight years and serve on their Pharmacist Recovery If elected, I will bring my experience as a leader and advocate for pharmacy to assist KPhA in meeting Network and their Legislative Committee. its strategic vision – to become a unified pharmacy profession empowered to maximize patient and public health as fully integrated members of the healthcare team. |10| Kentucky Pharmacists Association | March/April 2019

Kyle Harris It has been my privilege to be part of an amazing profession for nearly nine years. During that time, I have witnessed many changes to the profession which have granted pharmacists greater roles in providing patient care which have allowed patients more access to healthcare and quicker initiation of treatments.

Having worked in independent community pharmacy, specialty compounding and durable medical equipment, and long-term care, I have enjoyed learning of the impacts our profession can have on individual patients.

I have also enjoyed the opportunity to work with other healthcare providers to display the level of knowledge and expertise we are able to contribute to patient care from working with nurses, physician, and nurse practitioners in the skilled nursing facility to teaching physician assistants in the classroom.

I have been honored, in my relatively short time in this profession, to have worked with many great pharmacists who have paved the way for future pharmacists. I feel it is time for me to give back to my profession in this way--doing all we can to be certain the patients of the Commonwealth receive the care and attention we, as pharmacists, are educated and trained to provide.

tice in Kentucky Coalition (APPKC) and the APPKC Protocol Workgroup.

As the chair of the KPhA Provider Status Workgroup I am on the edge of my seat in anticipation of how our profession can blossom! Practicing as an associate professor at the Sullivan University College of Pharmacy I regularly see the excitement and anticipation of students eager to enter our profession. When interacting with currently practicing pharmacists this vigor has waned within the profession, leading to discontent, burnout and in extreme cases apathy. I am hopeful through the work of the KPhA Board, KPhA committees and the grassroots efforts of ALL KPhA members, we can revitalize the profession. Increasing our visibility as a profession, emphasizing our importance on the health care team, and truly becoming recognized as healthcare providers.

I will continue advocating for and working towards compensation for pharmacists’ professional services and innovative, sustainable practice models.

Through these avenues I believe pharmacists can reinvigorate their love and dedication for the profession!

I am asking for your vote so that I may continue serving on the KPhA Board of Directors, helping the profession step forward and fulfill the mission and vision of YOUR Kentucky Pharmacists Association.

Ethan Klein

Ethan Klein moved to Louisville following a PGY1 residency in The practice of pharmacy and serNorth Chicago. He started his career vice to the Commonwealth are very in Louisville as a clinical coordinaimportant to me as my roots are in tor, and worked with Rite Aid. ExKentucky; born and raised in Louisperience in hospital pharmacy, as a ville, KY and a 2010 graduate of the clinical coordinator, and a community pharmacist, University of Kentucky College of have helped shape his understanding of the differPharmacy. ent facets of pharmacy and his understanding of the My involvement with KPhA has significant challenges this profession faces. been personally and professionally rewarding. I am After completing his term as KPhA Speaker of the very grateful for the opportunities to serve my proHouse of Delegates, Ethan remained active within fession through KPhA, including service on the KPhA as a member of the Government Affairs New Practitioners Committee, Vice-Speaker and Committee. Last year, with other KPhA members, Speaker of the KPhA House of Delegates, and my he met with legislators to forward KPhA’s agenda current role, on the board of directors. I also serve in supporting changes to the Bio-similar Substituas a board member for the Jefferson Academy of tion bill. He is the 2015-16 co-chair of the ProfesPharmacy and on the Advancing Pharmacy Pracsional/Public Affairs Committee and also serves on Cassy Hobbs

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the Kentucky Pharmacists Political Advocacy Council.

Misty Stutz

As I have had the pleasure of servWith practical experience in multiple practice site ing on the professional affairs comsettings and my previous participation with KPhA mittee for the last 5 years, I have as Speaker of the House of Delegates in 2014, I feel gained an appreciation of the diffilike I would be an asset to the Board of Directors. culty of pulling the work of multiI’ve had two years experience on the board, and am ple committees together to give a familiar with the obligations the board has to the unified voice. And just as there are profession of pharmacy and the KPhA membermultiple voices within KPhA, ship. I would like the opportunity to serve again on there are also multiple voices withthe KPhA Board of Directors to continue to push in the state. But we all serve the same purpose, to forward KPhA’s legislative priorities, and I would advance the practice of pharmacy and be able to appreciate your vote. take care of our patients while maintaining fiscal solvency. I believe my talents of leadership and Jeff Mills teamwork could have a positive influence within Jeff Mills, PharmD., is a 2002 gradu- the leadership of KPhA. My experiences are diate of the University of Kentucky verse, and my role within the college of pharmacy College of Pharmacy and works for at Sullivan has allowed me to form a network of Norton Cancer Institute in Louispharmacists throughout the state that gives me a ville. His career has spanned comunique perspective to issues that arise regardless of munity, hospital and ambulatory practice site. All of us want the profession to contincare settings. Jeff’s practice interests ue to grow and expand, and yet each of us sees include oncology and legislative affairs. He has things a little differently. Being a member of the been an active participant on the KPhA Board of Board of Directors would allow me to work with Directors for over 15 years and has served as Speak- stakeholders to ensure KPhA was meeting the er of the House, Chair of the Public & Professional needs of not only our membership, but every pharAffairs Committee and a member of the KPhA Ex- macist throughout the state. We have made great ecutive Committee. Jeff resides in Louisville with strides within our profession within the last couple his wife, Janet, a pharmacist at KentuckyOne of years or so and I would like to be part of the posiHealth, and their two children, Rachel and Ryan. tive work from the Board of Directors to continue this forward momentum.

I am seeking to continue my service to the Kentucky Pharmacists Association on the Board of Directors for another term because I believe that active participation in advancing our profession is par- Ballots online and should be amount to the future of health care in Kentucky. submitted by May 4.

Pharmacy continues to be in a unique position to impact the lives of patients because of our accessiwww.kphanet.org/election-candidates bility and our specialized training in coaching our patients to better outcomes. With the advent of value based reimbursement and the focus on the overall health and well-being of patients, pharmacy has another opportunity to demonstrate that the role we play in patient care is critical. My practice experience – spanning ambulatory, inpatient and community practice settings – allows me to insightfully contribute to the decision making of the Board of Directors with the goal of positioning our profession to capitalize on these opportunities. I request your vote to allow me to continue serving our profession and our Association to that end. |12| Kentucky Pharmacists Association | March/April 2019

Advocacy Matters Ways you can support KPhA’s Advocacy efforts today! 

Participate in grassroots advocacy efforts

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Get to know your legislators—they should know your name

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Donate to the Political Advocacy Council and the Government Affairs Fund

Donate online to the KPhA Government Affairs Fund Funds contributed to KPhA Government Affairs are applied directly to our lobbying efforts in terms of staffing and contracted lobbying services. Company donations are acceptable for Government Affairs contributions, unlike contributions to Political Advocacy Funds, like KPPAC. Go to www.kphanet.org. |13| www.KPHANET.org

March CPE Article Opioid Use Disorder Naltrexone Therapy Protocol: Pharmacists on the Frontline By: Taylor Rostova, PharmD Candidate, Sarah Banday, PharmD, Amanda Jett, PharmD, BCACP The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

Universal Activity # 0143-0000-19-003-H01-P & T 1.0 Contact Hours (0.10 CEU) Expires 3/28/22 Goal: To educate pharmacists and pharmacy technicians on procedures and recommendations for the initiation, dispensing, and administration of naltrexone for medication assisted treatment to individuals for opioid use disorder recovery.

Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1.

Recognize Opioid Use Disorder and its prevalence in the state of Kentucky.

2.

Describe the mechanism of action of naltrexone.

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Apply the education and training entailed in the American Society of Addiction Medicine’s National Practice Guideline for the use of medications in the treatment of addiction involving opioid use by the Accreditation Council for Pharmacy Education.

4.

Practice new recommendations for the initiation, monitoring, and continuance of naltrexone therapy from the 2018 Naltrexone Therapy Protocol.

Introduction Opioid Use Disorder (OUD) is characteristically a chronic, relapsing illness, associated with strikingly increasing rates of morbidity and mortality. Opioids have analgesic and central nervous system depressant effects. They are used medically for pain relief and have the ill-fated potential to cause euphoria. OUD may involve prescription medications or the use of illegally obtained heroin. Patients with OUD who have attained abstinence are often presented with pharmacologic and non-pharmacologic options for the long-term maintenance of their recovery. In terms of opioids, studies have demonstrated that utilizing pharmacologic means in conjunction with behavioral health support provides a greater marked quality of life and opioid deterrent than either avenue alone.

downtown. In contrast, individuals who misuse opioids tend to do a good job of hiding their use. It can be much more difficult to spot than an alcoholic per se whose breath is a dead giveaway of their abuse. The Oath of a Pharmacist includes “I will consider the welfare of humanity and relief of suffering my primary concerns”, and ends with, “I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.”

Distinguishing patients in legitimate pain and identifying individuals in pursuit of prescription opioids for illicit reasons can often be quite challenging. Regrettably, the media sensationalism and pervasiveness of opioid use disorder has caused pharmacy personnel to look cynically at every opioid prescription that comes through the doors. While there is nothing wrong with being systematic, the fear of being deceived Contrary to common belief an opioid addict is not always the sometimes surpasses the call to alleviate the honest pain and stereotypical vagrant, disheveled user shooting up in an alley anguish of other patients. To find this equilibrium, pharmacists must grasp the applications of genuine pain and recogTable 4. Anaphylactic Epinephrine Dosages5 nize fraudulent drug-seeking behavior.

OUD has reached epidemic levels in the Bluegrass State. Fatal overdoses in Kentucky totaled 1,565 in 2017, an 11.5% increase over the previous year. It is critical that pharmacists and pharmacy technicians are educated on the practices for effectively communicating with both patients and providers |14| Kentucky Pharmacists Association | March/April 2019

Table 1. Differences Between Naloxone and Naltrexone

Naloxone

Naltrexone

Quickly reverses the effect of the drug

Slowly released into the body

Injected into patient suffering from an opioid overdose Now available as a take-home kit for Fentanyl overdose

Used for post-recovery once detox has occurred An aid to prevent substance abuse dependence

to augment opioid use. Pharmacists are on the forefront of healthcare and therefore on the frontline of the opioid abuse epidemic. As the gatekeepers of opioid medications, pharmacy staff should be aware of abuse-deterrent formulations and tools at their disposal. As of January 17th, 2018, pharmacist’s role as first responders expanded even further with the naltrexone therapy protocol.

Individuals 18 years or older diagnosed with OUD and meeting the inclusion criteria parameters are eligible for perprotocol status for naltrexone therapy under this protocol [Table 2]. Relevant medical and social history as outlined in the pharmacologic product guide includes an active diagnosis of opioid dependence disorder, a review of current medications, hypersensitivities, previous medication assisted therapy attempts and failures, and psychosocial counseling treatment Naltrexone Mechanism of Action plans. In addition to labs an assessment of hepatic and renal Naltrexone is available as an oral pill form or as an injectable. function will also be completed. An extensive list of the conThe pill form of naltrexone (ReVia ®, Depade®) can be taken traindications and precautions for initiation of therapy can be seen in Table 3. It is noteworthy that injection will not be proat 50 mg once per day and is used exclusively for the initial withdrawal challenge. The injectable extended-release form of vided to individuals with a positive opioid withdrawal assessthe drug (Vivitrol ®) is administered at 380 mg intramuscular ment. once a month. Like naloxone, naltrexone is a competitive an- During the assessment and screening process, validation of tagonist at opiate mu, kappa, and delta receptors. While both opioid abstinence for 7-10 days is required as well as a negamedications act to avert opioids from reaching the brain at a tive urine drug screen for opioids. An opioid withdrawal ascellular level, the difference lies in how they do so [Table 1]. sessment following the administration of naltrexone 25 mg Naloxone is a more rapidly acting drug which brings a patient orally (1/2 of a 50 mg tablet) will be performed to monitor out of an overdose, whereas naltrexone is slow acting and is patient for signs and symptoms of opioid withdrawal. Pharused to block the effects of opioids and alcohol. Naltrexone macists will need to complete the Clinical Opiate Withdrawal works by blocking opiate receptors via competitively occupy- Scale (COWS) prior to and following the 60-minute observaing receptors or displacing opiate agonists already occupied by tion period [Figure 1]. Additionally, if the patient is female receptors. Utilization of these mechanisms results in the eradi- and of child-bearing age, a negative urine pregnancy test will cation of the euphoric effect of opiates via displacing opiate 5 agonists from binding at the receptors or stopping opiate bind- Table 2. Protocol Criteria for Inclusion and Exclusion ing. If opiate concentrations are tremendously high, it is possiInclusion Criteria ble for the opiate to displace naltrexone. Should such a situation arise respiratory depression and death are possible. NalAble to provide informed consent trexone is not associated with tolerance or dependence; hence Adequately detoxified from opioids as verified by point-ofwithdrawal does not occur. Naltrexone does not antagonize the effects of non-opiates such as cocaine, ethanol, amphetacare urine drug screen mines, barbiturates, or benzodiazepines.

Had a baseline medical screening exam, including an evaluation of hepatic function within the past 14 days Education and Training No signs or symptoms of withdrawal as verified by Clinical Opiate Withdrawal Scale (COWS) The protocol approved on January 17th, 2018 encompasses Exclusion Criteria the criteria and procedures for pharmacists to initiate the dispensing and administration of naltrexone for medication asPregnant individuals sisted treatment to patients for OUD recovery. Pharmacists authorized to initiate the provision and administration of nal- Individuals with contraindications or a severe allergic reactrexone must receive training and education in OUD and nal- tion to naltrexone or any components of the extendedtrexone therapy in addition to a review of the American Socie- release injectable formulation ty of Addiction Medicine’s National Practice Guideline for Individuals with acute hepatitis or liver failure; or liver functhe use of medications in the treatment of addiction involving tion tests >3 times the upper limits of normal (ULN) opioid use by the Accreditation Council for Pharmacy EducaIndividuals testing positive for opioids via a point-of-care 5,6 tion or a Kentucky Board of Pharmacy approved provider. urine drug screen Patient Population also be necessary prior to initiating therapy. Currently there Naltrexone will only be initiated in judiciously selected perare no studies to assess the safety of naltrexone use in pregsons based on pertinent medical and social history and careful nant females.5 consideration of contraindications and safeguards of therapy. |15| www.KPHANET.org

Table 3. Contraindications and Precautions for Naltrexone Therapy 5

Contraindications and Precautions Hypersensitivity to naltrexone, or components of the naltrexone diluent Pregnancy Chronic opioid analgesics for chronic pain syndromes Current opioid dependence, including partial agonists Acute hepatitis or liver failure or liver function tests >3x ULN Positive urine drug screen for opioids Positive opioid withdrawal assessment- indicated

by COWS score 5 or greater o Injection will not be provided to individuals with positive opioid withdrawal assessment. (Opioid withdrawal assessment will be repeated in 24 hours.)

Any individual who has failed the naltrexone challenge test as evidenced by a change in COWS score of 2 or more Moderate to severe renal impairment History of thrombocytopenia or coagulation disorders

Anaphylaxis Management If all inclusion and assessment criteria are met, pharmacists will administer VivitrolÂŽ (380 mg) intramuscularly as instructed by the manufacturer and package insert. Even with vigilant screening and assessment, reactions can still occur.

The adverse events include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders.Therefore, patients will then be observed for 15 minutes to ensure there are no adverse reactions. Hallmark signs and symptoms of an anaphylactic reaction include: shortness of breath, generalized itching, erythema, urticaria, bronchospasm, shock, abdominal cramping or cardiovascular collapse. If the patient is to experience itching and swelling at the site of the injection only, they will need to be observed for a minimum of 30 minutes to ensure they do not progress into generalized symptoms. If the symptoms are generalized, call 911 immediately. Position the patient into a resting position and elevate their legs. Additionally. Administer 1-2 mg/kg of diphenhydramine every 4-6 hours for hives or generalized itching. Diphenhydramine can be administered orally or intramuscularly. However, if the patient is not fully alert and able to swallow safely do not administer orally!5 Monitoring and Continuance of Therapy Every 28 days + 2 days, subsequent naltrexone will be dispensed and administered if the patient can establish opioid abstinence for 7-10 days including a negative urine drug screen for opioids. If it has been greater than 30 days since their last injection, they will also require an opioid withdrawal assessment. Females of child-bearing age will need to have a negative urine pregnancy test prior to administration. Consistent with available clinical data, continuous therapy longer

than 12 months is not authorized under this protocol without overt approval from the authorizing practitioner.5 Patient Education While proper dispensing and administration of naltrexone is paramount, assuring that the patient understands the therapy is just as critical. A written medication guide will need to be provided to each patient at the initiation of their therapy [Figure 2]. Patients should not only understand the mechanism of action and benefits of naltrexone, but warnings and potential adverse reactions as well. It is crucial that the patient understand they must be opioid free for a period of 7-10 days to avoid triggering severe withdrawal. To optimize drug therapy patients should also be informed of the risk of overdose at the end of duration of effect period and consequently if a dose is missed or treatment is discontinued. Individuals receiving therapy will also be expected to carry or wear documentation of their treatment. It is imperative your patients know that the benefits of naltrexone therapy are demonstrated only when used in conjunction with a program that comprises counseling and support. There is an abundance of outside resources available to those recovering from addiction that are beneficial when combined with counseling treatment.5 The decision to seek treatment for addiction is not an easy decision and requires a great deal of trust between patients and their health care providers. As such, pharmacists should thrive in understanding and communicating the foundational issues at play in recovery. For instance, if a patient receiving naltrexone does not already have naloxone available the naloxone rescue medication should be provided under the pharmacist naloxone protocol. Once the difficult decision to seek Table 5. Management of Adverse Reactions5

For All Adverse Reactions Monitor the patient closely checking their vitals every 2 -5 minutes.

Keep individual in recumbent position unless they are having breathing difficulty.

If they are having difficulty breathing, you can elevate their head assuming their blood pressure is adequate to prevent loss of consciousness. If their blood pressure is low elevate their legs.

Perform CPR if necessary to maintain airway.

Inform the authorizing practitioner and their primary care provider if applicable, as soon as possible. treatment has been made, it is important these patients are equipped to avoid relapse in the future.

Documentation and Notification Pharmacists are required to document by means of prescription record each patient receiving naltrexone under this protocol. Proper documentation as required in 201 KAR 2:170 for the dispensing of prescription medication and confirmation of informed consent will be requisite for each patient. Patient education and care plan must also be documented; including confirmation of opioid abstinence and results of the naltrexone challenge, if applicable. In addition to the location of the

|16| Kentucky Pharmacists Association | March/April 2019

injection, pharmacists will need to initial or list provider’s NPI who suffer from drug or alcohol dependence to maintain abwith the medication lot and expiration numbers. stinence. As pharmacists we must empathize with our patients to work toward a meaningful resolution.

Primary care providers are to be notified within two business days of dispensing and administration under naltrexone proto- References col. In the absence of a primary care provider, the patient will be referred for a medical evaluation prior to initiating therapy. 1. Strain E. Pharmacotherapy for opioid use disorder. UpToDate. https://www-uptodateIf the medication is terminated by the individual or administration is not necessary under the circumstances of the proto- com.suscorp.idm.oclc.org/contents/pharmacotherapy-forcol, notification to the primary care provider within 2 days is opioid-use-disorder?search=opioid use disorder eric likewise required. Under the directions of the authorizing pro- strain&source=search_result&selectedTitle=1~150&usage_ty pe=default&display_rank=1.Accessed September 9, 2018. vider, the pharmacist will provide written notification by means of fax or other secure electronic means to the authoriz- 2. Oath of a Pharmacist. APhA. ing practitioner of the individual receiving naltrexone therapy https://www.pharmacist.com/oath-pharmacist. Accessed under this protocol within 7 days of initiating dispensing. 5 September 9, 2018.

Stepping Up to the Front Line We must come to terms with where we are as a community, as a state, and as a nation. Kentucky has reached a record high exceeding 1,500 drug-related deaths each year. The statistics speak volumes to the widespread crisis we are facing.

The tragedy of lives lost to overdose today and the inevitable dozens of others that are to follow in the months to come serve as a painful reminder that what we consider rock bottom is nothing in comparison to the ultimate rock bottom: death.

While naltrexone will not cure addiction, it can help many Figure 1. Clinical Opiate Withdrawal Scale 5

3. Tilley JC, Ingram V. Overdose Fatality Report. Office of Drug Control Policy. https://odcp.ky.gov/Pages/OverdoseFatality-Report.aspx. Accessed September 14, 2018.

4. Naltrexone. Clinical Pharmacology. https://wwwclinicalkeycom.suscorp.idm.oclc.org/pharmacology/monograph/426?se c=monmech. Published February 7, 2009. Accessed September 16, 2018.

5. Board Approved Protocols. Kentucky Board of Pharmacy Home. https://pharmacy.ky.gov/Pages/Board-ApprovedProtocols.aspx. Accessed October 2, 2018.

6. American Society of Addiction Medicine. American Society of Addiction Medicine.

|17| www.KPHANET.org

Figure 2. Vivitrol Medication Guide 7 www.vivitrol.com/content/pdfs/medication-guide.pdf

https://www .asam.org/re sources/guid elines-andconsensusdocuments/npg.

Accessed September 18, 2018 7. Vivitrol [package insert]. Waltham, MA: Alkermes; 2015

|18| Kentucky Pharmacists Association | March/April 2019

March 2019 — Opioid Use Disorder Naltrexone Therapy Protocol: Pharmacists on the Frontline

1. Which of the following is true regarding naltrexone’s mechanism of action?

B. Yes, because she is only in her first trimester of pregnancy.

A. Naltrexone is a rapidly acting drug which brings a patient C. Yes, because naltrexone is Category B. out of an overdose.

D. No because she is pregnant and there are no adequate and well-controlled reproduction studies in humans.

B. Naltrexone is slow acting and is used to block the effects of opioids and alcohol.

E. No, patients must be 21 years or older to receive naltrexone therapy.

C. Naltrexone acts to antagonize the effects of non-opiates such as cocaine, ethanol, amphetamines, barbiturates, or 5. During the assessment and screening process, which of benzodiazepines. the following is required?

D. Naltrexone works by blocking opiate receptors via comA. Validation of opioid abstinence for 5 days is required as petitively occupying receptors or displacing opiate agowell as 2 consecutive negative urine drug screens for opinists already occupied by receptors. oids.

E. Naltrexone is associated with tolerance or dependence B. Validation of opioid abstinence for 14 days is required as therefore withdrawal does not occur. well as a negative urine drug screens for opioids.

2. Which of the following is true regarding naltrexone C. An opioid withdrawal assessment following the adminavailability? Select all that apply. istration of naltrexone 25 mg orally.

A. Naltrexone is available as an oral pill form or as an injectD. An appointment for psychosocial counseling must be able scheduled and confirmed prior to administration.

B. The pill form of naltrexone is used exclusively for the iniE. A baseline medical screening exam, including an evaluatial withdrawal challenge. tion of hepatic function within the past 7 days.

C. The injectable extended-release form of the drug (Vivitrol) 6. During 15-minute observation period patient begins exis used exclusively for the initial withdrawal challenge. hibiting generalized itching and shortness of breath. The D. Vivitrol is administered at 380 mg intramuscular once a pharmacy technician has dialed 911 and EMS is on the way. month.

What can you do for the patient until EMS arrives?

E. Depade ® can be taken at 50 mg twice per day.

3. Pharmacists authorized to initiate the provision and administration of naltrexone must complete which of the following?

A. Training and education in Opioid Use Disorder and naltrexone therapy.

B. Review of the 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.

C. Review of the 2016 Pain Management Practice Guideline.

D. Comprehensive review of Substance Abuse Psychology

A. Position the patient into fetal position and elevate their head.

B. Position the patient into a resting position and elevate their arms.

C. Administer 4 mg/kg of diphenhydramine every 2 hours.

D. Administer naloxone.

E. To further address anaphylaxis, EpiPen® 0.30 mg can be repeated every 5 to 15 minutes for up to 3 doses until EMS arrives.

7. If the patient can establish opioid abstinence for 7-10 days including a negative urine drug screen for opioids, subsequent naltrexone will be dispensed and administered:

E. Review of the Practice Guideline for the Pharmacological A. Treatment of Patients with Alcohol Use Disorder.

B. 4. KB is a 18 y/o AAF who presents to your clinic with her C. friend who is currently taking naltrexone and wants to know if she is also a candidate for therapy? KB is 8 weeks D. pregnant and wants to do the right thing for her unborn child. KB has documentation that she is adequately detoxi- E. fied from opioids as verified by point-of-care urine drug screen. Is KB a candidate for naltrexone therapy?

Every 4-6 hours as needed.

Every 28 days + 2 days Every 4 weeks.

Every 7-10 days.

Daily for 30 treatment period.

A. Yes, because she is detoxified from opioids as verified by point-of-care urine drug screen. |19| www.KPHANET.org

March 2019 — Opioid Use Disorder Naltrexone Therapy Protocol: Pharmacists on the Frontline Cont.

8. If it has been 30 days since their last injection, what else will be required of the patient?

10. Pharmacists are required to document which of the following?

A. A negative urine pregnancy test if they are female and of child-bearing age.

A. Drug appearance.

B. Medication reconciliation.

B. Pharmacy DEA. C. Medication prescription number.

C. Review of the National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use.

D. Temperature logs.

E. Confirmation of opioid abstinence.

D. Comprehensive metabolic profile.

E. Nothing the patient can receive Vivitrol 380 mg intramuscularly.

9. While proper dispensing and administration of naltrexone is important, assuring that the patient understands the therapy is just as critical. In addition to a written medication guide, what other information will you need to provide your patient?

A. They must be opioid free for a period of 14 days to avoid triggering severe withdrawal.

B. The benefits of naltrexone therapy are demonstrated only when used without counseling and support.

C. The risk of overdose at the end of duration of effect period and consequently if a dose is missed or treatment is discontinued.

D. Individuals receiving therapy are not expected to carry or wear documentation of their treatment.

E. Sharps container disposal services in the surrounding area

KPERF Launches New Continuing Education Online Platform In the coming weeks we will be transitioning to a new Continuing Education platform.

In the past year we have integrated online CPE, but it was not a comprehensive online solution. Now, when you complete your CPE article activities online the credits will be automatically sent to CPE Monitor. You can also begin an activity, pause, and come back to complete the credits. You will also receive an email once your activity is complete, so that you can keep track of the activities you complete. We will continue to allow for mailed quiz submissions, but highly recommend that you try out the new platform!

Please contact Sarah Franklin (sarah@kphanet.org or 502.227.2303) with any questions. We are happy to assist you in obtaining your FREE CPE credits through The Kentucky Pharmacist!

2019 Articles: www.kphanet.org/the-kentucky-pharmacist-cpe-articles-2019 2018 Articles: https://www.kphanet.org/2018-continuing-education-articles |20| Kentucky Pharmacists Association | March/April 2019

This activity is a FREE service to members of the Kentucky Pharmacists Association.

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 3/28/2022 Successful Completion: Score of 80% will result in 1.0 contact hour or .10 CEUs. TECHNICIANS ANSWER SHEET March 2019 — Opioid Use Disorder Naltrexone Therapy Protocol: Pharmacists on the Frontline (1.0 contact hour) Universal Activity # 0143-0000-19-003-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D E 5. A B C D E 7. A B C D E 9. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. A B C D E 10. A B C D E Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #__________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET March 2019 — Opioid Use Disorder Naltrexone Therapy Protocol: Pharmacists on the Frontline (1.0 contact hour) Universal Activity # 0143-0000-19-003-H01-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS:

1.

2.

ABCDE ABCDE

3. A B C D E 4. A B C D E

5. A B C D E 6. A B C D E

7. A B C D E 8. A B C D E

9. A B C D E 10. A B C D E

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted. |21| www.KPHANET.org

|22| Kentucky Pharmacists Association | March/April 2019

Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines The following broad guidelines should guide an author to  completing a continuing education article for publication in The Kentucky Pharmacist.  



Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).



Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not  pertinent to technicians, that needs to be stated clearly at the beginning of the article.



Article should begin with the goal or goals of the overall program – usually a few sentences.



Include 3 to 5 objectives using SMART and measurable verbs.



Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.



Include a quiz over the material. Usually between 10 to 12 multiple choice questions.

Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.

When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.

Articles should address topics designed to narrow gaps between actual practice and ideal practice in pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see previously published articles.

Articles must be submitted electronically to the KPhA director of communications and continuing education (info@kphanet.org) by the first of the month preceding publication.

|23| www.KPHANET.org

April CPE Article Update on the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ ADA/AGS/APhA/ASPC/NLA/PCNA Cholesterol Guideline By: Natalie N. Conley, PharmD candidate, Stacy A. Taylor, PharmD, MHA, BCPS, Tracy E. Macaulay, PharmD, AACC, BCPS, University of Kentucky College of Pharmacy The author declares that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Universal Activity #0143-0000-19-004-H01-P&T 1.0 Contact Hour (0.10 CEU) Expires 3/28/2022

Goal: To aid pharmacists, pharmacy interns, and pharmacy technicians in understanding the new cholesterol guideline and how the changes will affect the management of cholesterol in their patients.

Learning Objectives: At the conclusion of this knowledge-based article, the reader should be able to: 1.

Contrast the recommendations in the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Cholesterol Guideline as compared to the 2013 ACC/AHA Cholesterol Guideline.

2.

Recommend treatment for patients who fall into a treatment benefit group and include recommendations for specific LDL lowering goals as appropriate.

3.

Provide recommendations for the addition of other medications to statin therapy in patients who do not achieve LDL goals on a maximally tolerated statin.

4.

Incorporate lifestyle therapies that are recommended for lowering blood cholesterol and prevention of atherosclerotic events.

Introduction The 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/ APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol1 replaces the 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guideline on the Treatment of Blood Cholesterol.2 The new guideline was written with the purpose of addressing the practical management of patients with high blood cholesterol and related medical conditions. These recommendations were created following an extensive evidence review and each recommendation is designated with a class of recommendation (COR) corresponding to the strength of the recommendation and a level of evidence (LOE) which designates the nature and source of the supporting data. A description of these is provided in Table 1.

Similar to the guideline released in 2013, the new guideline places an emphasis on using statins in the treatment and prevention of atherosclerotic cardiovascular disease (ASCVD).1 Four treatment benefit groups continue to delineate patients most likely to benefit from statin therapy. Recommendations for patients with established clinical ASCVD now include guidance for the addition of non-statin therapy. For the other three statin benefit groups, the initiation and intensity of treatment as well as addition of non-statin therapy is now guided by evaluation of additional risk features such as diabetes- spe-

cific risk enhancers, ASCVD risk enhancing factors and coronary artery calcium (CAC) scoring in select patients. The four treatment groups are: 1.

Secondary ASCVD Prevention

2.

Severe Hypercholesterolemia (LDL-C ≼190 mg/dL)

3.

Diabetes Mellitus in Adults 40-75 Years of Age With LDL- C 70-189 mg/dL

4.

Primary Prevention based on ASCVD risk

Statin dosing can be divided into high-, moderate- and lowintensity categories and the level of LDL-lowering varies between the three. High-, moderate- and low-intensity statins along with doses can be found in Table 2. Detailed recommendations for treating patients that fall in each benefit group can be found in the subsequent sections.

Unlike the 2013 guideline, the new guideline now emphasizes achieving specific treatment goals for the lowering of lowdensity lipoprotein cholesterol (LDL-C) for specific categories of patients.1 The 2018 guideline also provides more information on non-statin cholesterol lowering agents including when to recommend ezetimibe, bile acid sequestrants and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Of the non-statin therapies, ezetimibe is the most commonly recommended add on agent when compared to bile

|24| Kentucky Pharmacists Association | March/April 2019

Table 1: Class of Recommendation and Level of Evidence1 Class (strength) of recommendation Level of Evidence

Class I (strong) Benefit >>>Risk

Class IIa (moderate)

Benefit > Risk

Benefit >> Risk

Level A High quality evidence from multiple RCTs or meta-analyses

Class IIb (weak)

Level B-R (randomized)

Level B-NR (nonrandomized)

Moderate quality evidence from 1 o more RCTs or meta-analyses

Moderate quality evidence from 1 or more nonrandomized studies

acid sequestrants and PCSK9 inhibitors. Other LDL-C lowering agents such as niacin and fibrates are not recommended as add on therapy with statins due to lack of randomized controlled trial support. Fibrates may be considered for triglyceride lowering in patients with fasting triglyceride of 500 mg/dL or higher to decrease the risk of acute pancreatitis.1 Benefit Group 1: Secondary ASCVD Prevention

Class III: No Benefit (moderate) Benefit = Risk Level C–LD

Class III: Harm (Strong)

(limited data)

(expert opinion)

Randomized or nonrandomized with limitations

Consensus of opinion based upon clinical experience

Risk> Benefit Level C–EO

Benefit Group 2: Severe Hypercholesterolemia (LDL-C ≥190 mg/dL) The second patient management group encompasses those patients with severe hypercholesterolemia defined as LDL-C ≥ 190 mg/dL. Patients 20-75 years old with severe hypercholesteremia should be placed on the maximally tolerated statin therapy (I,B). If LDL-C remains greater than 100 mg/dL on maximally tolerated therapy and/or the patient has not achieved a 50% reduction in their LDL-C, ezetimibe can be considered as add-on therapy (IIa,B). In patients who have not achieved a 50% reduction in LDL-C while on both a maximally tolerated statin and ezetimibe, a bile acid sequestrant can be considered for additional therapy as long as fasting triglycerides are £ 300 mg/dL (IIb,B). In patients who fall between the ages of 30 and 75 years who have heterozygous familial hypercholesterolemia (FH), with LDL-C levels of 100 mg/dL or greater while on combination therapy of ezetimibe and a maximally tolerated statin, a PCSK9 inhibitor can be considered for additional therapy (IIb,B). Of note, the previous guideline did not place PCSK9 inhibitors into the guideline-directed armamentarium for this benefit group. The 2018 guideline is the first to do so, however the guideline expresses concern that the use of a PCSK9 inhibitor in this patient population is of uncertain value due to the high cost of therapy.1

The first patient management group encompasses those with clinical ASCVD. ASCVD includes acute coronary syndrome (ACS), history of myocardial infarction (MI), stable or unstable angina, stroke, transient ischemic attack (TIA), history of coronary or other revascularization procedure, or peripheral artery disease (PAD). When addressing patients who fall into the secondary ASCVD prevention category, they can be further categorized into patients who have very high-risk ASCVD and stable ASCVD. Those patients with very highrisk ASCVD have a history of multiple major ASCVD events or one major event and multiple high-risk conditions. The guideline defines specific events that should be categorized as major ASCVD events including a recent ACS occurring within the past year, any history of MI, any history of ischemic stroke, or symptomatic PAD. Similarly, high-risk conditions are defined in the guideline as age ≥ 65 years, heterozygous familial hypercholesterolemia, heart failure, prior coronary artery bypass graft surgery or percutaneous coronary interven- Benefit Group 3: Diabetes Mellitus in Adults 40-75 Years of tion, diabetes, hypertension, chronic kidney disease, current Age With LDL-C 70-189 mg/dL smoking, and persistently elevated LDL-C ≥ 100 mg/dL.1 In patients with diabetes mellitus who are between 40 and 75 Stable ASCVD: In patients who are 75 years old or younger years of age and have an LDL-C between 70-189 mg/dL, with stable ASCVD, a high- intensity statin should be started moderate-intensity statin therapy is recommended (I,A). Simi(I,A). In patients who are older than 75 years with stable lar to the 2013 guideline, some diabetic patients are at greater ASCVD, patients can begin moderate- or high-intensity statin ASCVD risk and warrant high-intensity statin therapy. In the therapy after evaluation by the clinician (IIa, BR). If a highprevious guideline, these higher risk diabetic patients were intensity statin is not tolerated or if the high dose is clinically determined through assessment of the 10-year ASCVD risk. contraindicated, moderate-intensity statin therapy should be The new guideline determines higher risk diabetic patients used (I,A).1 using a new strategy. As shown in Table 3, a new list of Diabetes-Specific Risk Enhancers has been compiled to aid in Very High-Risk ASCVD: If a patient is determined to have determining which diabetic patients are at higher risk. In pavery high-risk ASCVD, high- intensity statin therapy or the tients with multiple Diabetes-Specific Risk Enhancers, it is maximally tolerated statin therapy should be initiated (I,A). If reasonable to recommend high-intensity statin therapy (IIa, a patient continues to have an LDL-C greater than or equal to B). Additionally, when considering a diabetic patient’s age the 70 mg/dL on maximally tolerated statin therapy, it is reasona- guideline provides two general recommendations. Diabetic ble to consider the addition of ezetimibe (IIA,B). If a patient is patients 50 to 75 years are at increased ASCVD risk and it is on both a maximally tolerated statin and ezetimibe but still reasonable to recommend high-intensity statin therapy in this has LDL-C greater than or equal to 70 mg/dL, the addition of age group. Similarly, diabetic patients older than 75 years cona PCSK9 inhibitors can be considered (IIa,A).1 tinue to remain at high risk for ASCVD events. In patients who are already taking statin therapy it is reasonable to con-

|25| www.KPHANET.org

Table 2: Statin Intensity1 High Intensity (≥ 50 % LDL-C lowering) Atorvastatin (40 mg*) 80 mg

Moderate Intensity (30% - 49% LDLC lowering) Atorvastatin 10 mg (20mg)

Low Intensity (< 30% LDL-C lowering)

Rosuvastatin 20 mg-40 mg

Rosuvastatin (5 mg) 10 mg

Pravastatin 10-20 mg

Simvastatin 20-40 mg

Lovastatin 20 mg

Pravastatin 40 mg (80 mg)

Fluvastatin 20-40 mg

Simvastatin 10 mg

Lovastatin 40 mg (80 mg) Fluvastatin XL 80 mg Fluvastatin 40 mg BID Pitavastatin 1-4 mg Italicized type: these statins and doses have been assessed by randomized controlled trials as well as meta-analyses.

Statins not italicized are those doses that are approved by the FDA but were not assessed by randomized controlled trials. * Evidence for this specific dose of atorvastatin was only found in one randomized controlled trial. tinue the statin therapy beyond 75 years of age (IIa,B). The guideline even goes on to provide a weak recommendation to consider initiation of statin therapy in patients older than 75 years who have not previously been taking statin therapy (IIb,C). This is recommended to be in conjunction with a clinician-patient discussion of the potential risks and benefits associated with therapy.1 Table 3: Diabetes Specific Risk Enhancers1 Duration Type 1 Diabetes Mellitus: ≥ 20 years Type 2 Diabetes Mellitus: ≥ 10 years eGFR <60 ml/min/1.73 m2 Retinopathy Neuropathy Albuminuria ≥ 30 mcg of albumin/mg creatinine Ankle-brachial index <0.9

calculated. The higher the estimated risk for a patient, the more likely the patient is to benefit from the recommended, evidence-based statin drug therapy. In determining overall ASCVD risk in primary prevention, the 2018 guideline also includes the additional consideration of “ASCVD Risk Enhancing Factors” which can be found in Table 4. These enhancers can be used when discussing the risk of each patient and can be used to determine if a patient would benefit from statin therapy.1 Patients with a 10-year ASCVD risk less than 5% are considered “low risk” and emphasis should be placed on lifestyle modifications to reduce risk (I,A). Risk between 5% and 7.5% is considered “borderline risk.” In patients with borderline risk who have ASCVD risk-enhancing factors present, the guidelines provide a weak recommendation for considering moderate-intensity statin (IIb,B). ASCVD risk of 7.5% up to 20% is considered “intermediate risk” and if ASCVD risk enhancing factors are present then moderate-intensity statin therapy should be initiated (I,A). Lastly, risk of 20% or greater is considered “high risk” and high-intensity statin therapy should be initiated (I,A).1

This 2018 guideline also includes recommendations for coronary artery calcium (CAC) scoring. CAC scoring is useful in moderate risk patients where it remains uncertain if statin Benefit Group 4: Primary Prevention Over the Life Span therapy is warranted for a patient. A CAC score of zero indiWhen considering primary prevention, patients with LDL-C cates a low ASCVD risk for the following ten years and therefore would allow the potential withholding of statin therapy ≥ 190 mg/dL and patients with diabetes fall into higher-risk categories of primary prevention and have been addressed in in that patient (IIa,B). These patients should be reassessed in other benefit groups. The remaining patients requiring prima- 5-10 years. However, if a patient is a cigarette smoker, has ry prevention over the life span can be further subdivided into diabetes mellitus, has a chronic inflammatory disease, or has a family history of ASCVD this patient may still have a subthree age categories. In patients between 0 and 19 years of age the primary focus should be on education on healthy life- stantial 10-year ASCVD risk despite the CAC score of zero. If styles to reduce their lifetime risk of ASCVD. Patients of this a patient has a CAC score of 100 Agatston units or higher, they most likely have an ASCVD risk of 7.5% or greater and age range with familial hypercholesterolemia should be placed on statin therapy. In patients between 20 and 39 years in these patients moderate-intensity statin therapy is recommended (IIa, B). In a patient whose CAC score falls between of age statin therapy should be considered for individuals those two groups with a score of 1-99, it is reasonable to start with a family history of premature ASCVD and an LDL-C greater than or equal to 160 mg/dL. Otherwise, lifestyle mod- statin drug therapy if the patient is 55 years or older (IIa, B). ifications should be encouraged. Patients between the ages of Patients Outside the Four Benefit Groups and Special Pop40 and 75 years with LDL-C between 70 mg/dL and 190 mg/dL without diabetes should have a 10-year ASCVD risk ulations |26| Kentucky Pharmacists Association | March/April 2019

Table 4: ASCVD Risk Enhancing Factors1 

Family history of premature ASCVD Males: < 55 years of age Females: < 65 years of age



Metabolic syndrome (3 from the list below) Increased waist circumference Triglycerides >175 mg/dL Hypertension Hyperglycemia Low HDL-C (<40 mg/dL for men, <50 mg/dL for women)



Chronic kidney disease (not treated with transplantation or dialysis, eGFR 15-59 ml/min/1.73m2)



Chronic inflammatory conditions



Female specific risk enhancers: Premature menopause (before age 40) History of pregnancy associated conditions that can later increase ASCVD such as preeclampsia



High-risk ethnicities (South Asian, etc.)



Lipid/biomarkers Elevated, primary hypertriglyceridemia (≥ 175 mg/dL) Elevated high-sensitivity C-reactive protein Ankle-brachial index <0.9 Elevated Lp(a) (≥ 50 mg/dL or ≥ 125 nmol/L) Elevated apoB (≥ 130 mg/dL)

The guideline addresses several patient populations who fall outside the four primary benefit groups who may still benefit from careful consideration of the potential risks and benefits of initiating statin therapy. In adults without clinical ASCVD who are older than 75 years of age with an LDL-C level of 70189 mg/dL, moderate-intensity statin may be considered for primary prevention (IIb,B). If patient has functional decline, frailty, or reduced life expectancy it is reasonable to stop statin therapy (IIb,B). If an adult is between the ages of 76 and 80 years of age measuring a CAC score could be reasonable to determine the necessity of statin therapy (IIb,B).1

a statin. Having experienced menopause before the age of 40 or having a history of pregnancy-associated disorders (gestational diabetes, preterm deliveries, hypertension, preeclampsia, etc.) are risk enhancing factors that should be considered when determining drug therapy (I,B).3

For patients who suffer from chronic kidney disease but are not being treated with dialysis or kidney transplantation, moderate-intensity statin as monotherapy or in combination with ezetimibe can be considered (IIa,B). In patients with dialysisdependent advanced kidney disease it is reasonable to continue statin therapy that has previously been initiated (IIb,C).

If a child or adolescent has a lipid disorder secondary to obesi- Initiation of a statin in these patients is not recommended (III: ty, lifestyle therapy should be emphasized (I,A). Lifestyle no benefit, B).1 counseling can be beneficial for children and adolescents who Patients with Human Immunodeficiency Virus (HIV) or are having lipid irregularities (I,B). In a child ≥ 10 years old chronic inflammatory disorders are at higher risk for ASCVD with an LDL-C ≥ 190 mg/dL or with an LDL ≥ 160 mg/dL and potential risk/benefits should be discussed in determining with a presentation of familial hypercholesterolemia who is moderate-intensity versus high-intensity statin therapy recomnot responding to changes in lifestyle, statin therapy can be 1 mendations (IIa,B). Prior to the initiation of and 4-12 weeks considered (IIa,B). after starting inflammatory disease modifying therapy or anWomen of childbearing age who are currently being treated tiretrovirals, a fasting lipid profile and an assessment of with a statin should be counseled on reliable types of contraASCVD risk factors can be helpful in the discussion of statin ception if they are sexually active (I,C).1 If a woman of therapy benefit and monitoring of therapy (IIa, B). It also may childbearing age has plans to become pregnant, it is recombe helpful in patients with rheumatoid arthritis to check a lipid mended that they stop statin therapy 1-2 months before atprofile and reevaluate risk factors 2-4 months after a patient’s tempting to become pregnant. If a woman discovers she is disease is under control (IIa,B).1 pregnant while on a statin therapy, the statin should be stopped immediately (I,C). Currently all statins are contraindicated in pregnancy. Women, specifically, have certain risk factors that should be considered when thinking about adding |27| www.KPHANET.org

PCSK9 inhibitors include Alirocumab and Evolocumab. Both are available as subcutaneous injections and combined with Prior to the initiation of pharmacotherapy, baseline LDL-C statin therapy can lower LDL-C by an additional 45-65%. levels can be assessed using a fasting or non-fasting lipid panel While the PCSK9 inhibitors seem to be tolerated well by pasince there are typically only small differences in levels betients, there is a lack of long-term safety data available. As tween fasting and non-fasting samples. In patients on pharma- these agents are monoclonal antibodies, they are expensive cotherapy for high cholesterol, measurement of fasting lipids medications. It is important to consider the cost when thinkshould be done four to twelve weeks after the initiation of ing about adding one to a patient’s medication regimen.1 statin therapy or after any adjustment in dosage. Once a patient is on an established regimen, lipids should then be reas- PCSK9 inhibitor therapy is recommended in patients with clinical ASCVD and those with LDL-C ≥ 190 mg/dL who sessed every three to twelve months based upon individual have been taking maximally tolerated statin therapy along patient need (I,A). It is expected that therapy with highwith ezetimibe but have not met the necessary treatment intensity statins will decrease LDL-C by approximately 50% goals. In clinical ASCVD, a PCSK9 inhibitor is recommended and therapy with moderate-intensity statins will decrease for patients who are still considered to be at very high-risk LDL-C by 30-50%.1 after the implementation of maximally tolerated statin therapy Non-Statin Drug Therapies and ezetimibe (I,B). While PCSK9 inhibitors are noted to be very effective in lowering LDL-C and beneficial in reducing The 2013 guideline lacked guidance on the addition of noncardiovascular events, the guideline rated the pharmacoecostatin therapies in the treatment of high blood cholesterol.2 In nomic value as “low cost value” based on the high acquisition 2016, the ACC released their Expert Consensus Decision cost of these agents at the time of publication. Of note, the Pathway on the Role of Non-Statin Therapies for LDLprices of PCSK9 inhibitors are beginning to decrease considerCholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk4 which gave direction on when ably which may allow for earlier prioritization of these therato add other therapeutic options on to statin therapy. The new pies in the future. In a patient with severe hypercholesterolemia, PCSK9 inhibitors can be considered in patients between 2018 cholesterol guideline, includes evidence-based support to 30 and 75 years of age who have a diagnosis of heterozygous guide clinicians in the addition of other drug therapies in familial hypercholesterolemia and an LDL-C greater than or treating patients with high blood cholesterol. It is important to note that these therapies should not replace the statin therapy equal to 100 mg/dL on dual therapy with a statin and a patient is already taking but are indicated to be used in con- ezetimibe (IIb,B).1 Monitoring

junction with the statin therapy. These non-statin therapies include ezetimibe, PCSK9 inhibitors, and bile acid sequestrants.1

Bile acid sequestrants include cholestyramine, colestipol and colesevelam. These agents work by binding with bile acids to form a complex that cannot be absorbed in the intestine. This inhibition of reuptake of bile salts increases the loss of bile Ezetimibe inhibits cholesterol absorption at the brush border salts and bile acid-bound LDL-C in the feces.5 The addition in the small intestine through the NPC1L1 transporter. Less cholesterol is delivered to the liver which leads to less storage of a bile acid sequestrant to a statin can increase LDL-C lowof cholesterol in the liver. Overall, this leads to an increase in ering by 15-30%. Adverse effects consist of mostly gastrointestinal issues such as constipation, abdominal pain/cramping, the clearance of blood cholesterol and a decrease in LDL-C.6 and intestinal gas.6 Bile acid sequestrants are not commonly The addition of ezetimibe to statin therapy can lower LDL-C used as add-on therapy but can be considered in patients who by an additional 12-20%. Ezetimibe is the most commonly used add-on agent and has a low incidence of adverse effects. fall into the second benefit group (baseline LDL-C ≥190 mg/dL). If a patient age 20-75 years with baseline LDL-C ≥ The guideline specifically recommends two major clinical 190 mg/dL without a diagnosis of familial hypercholesterolescenarios in which ezetimibe should be added to maximally mia has not achieved a 50% reduction in LDL-C levels while tolerated statin therapy. The first is when the LDL-C level taking maximal statin therapy and ezetimibe, a bile acid seremains above 70 mg/dL in patients taking maximally toleratquestrant may be added (IIb,B). Since bile acid sequestrants ed statin therapy to treat very-high risk ASCVD, ezetimibe have an adverse effect of increasing triglycerides, this recomcan be added (IIa, A). The second is when the LDL-C level mendation also includes the caveat that triglycerides should remains above 100 mg/dL in a patient who falls in the benefit be 300 mg/dL or less before initiating a bile acid sequestrant.1 group of patients with LDL-C ≥ 190 mg/dL after the initiation of maximally tolerated statin therapy, ezetimibe can be Lifestyle Therapies added for further LDL-C lowering (IIa,B).1 In 2013, the AHA/ACC released a lifestyle modification PCSK9 inhibitors are human monoclonal antibodies that bind guideline that is referenced in the new cholesterol guideline.7 to PCSK9.5 In the normal state, the PCSK9 protein binds to These include specific recommendations for diet and exercise the LDL receptors on hepatocytes leading to enhanced degra- in order to manage both blood cholesterol and blood pressure. dation of LDL receptors. Without sufficient LDL receptors, This section will focus on the recommendations that relate to the liver is impaired in its ability to clear LDL from the blood. the management of blood cholesterol, specifically. Lifestyle When a PCSK9 inhibitor is administered, this binding of management is a major component in the prevention and PCSK9 to LDL receptors and subsequent degradation of LDL treatment of ASCVD and it is seen throughout the new 2018 receptors does not occur. Taking a PCSK9 inhibitor increases guideline.1 the number of LDL receptors in the liver which serve the purpose of decreasing circulating LDL in the blood.5 Available |28| Kentucky Pharmacists Association | March/April 2019

For adults that would benefit from a lower LDL-C, the lifestyle management guideline emphasizes a diet that includes vegetables, fruits, and whole grains. It also suggests inclusion of low-fat dairy products, poultry, fish, legumes, non-tropical vegetable oils, and nuts. The guideline advises that sweets, beverages sweetened with sugar and red meats be limited (I,A). Patients can achieve this by following dietary plans such as the dietary approaches to stop hypertension (DASH) pattern, the United Stated Department of Agriculture (USDA) pattern or the American Heart Association (AHA) diet. Patients should adjust their dietary pattern to appropriate caloric requirements, personal and cultural preferences, and nutrition therapy for other medical conditions (I,A). Dietary patterns should aim for 5% to 6% of calories from saturated fat and a reduction of calories from trans fat (I,A).

To reduce LDL-C and non HDL-C, it is advised that adults engage in aerobic physical activity three to four times per week for an average of 40 minutes per session. This should include moderate- to vigorous-intensity physical activity (IIa,A).

Outcomes Following Publishing of 2018 Guideline Schwartz, et al released an article regarding ODDYSEY OUTCOMES in the New England Journal of Medicine in November of 2018.8 This clinical trial aimed to establish whether alirocumab would improve the cardiovascular outcomes in patients following an acute coronary syndrome who were on high-intensity statin therapy. This randomized, double-blind, placebo-controlled trial involved over 18,000 patients. The results of this trial indicate that in patients who have had a previous acute coronary syndrome with high lipid levels even when taking high-intensity statin therapy, the risk of death from major cardiovascular events was lower in those treated with alirocumab when compared to those who received placebo.

Bhatt and colleagues also published a cardiovascular outcomes trial in November 2018 in the New England Journal of Medicine aimed at evaluating cardiovascular outcomes with the use of icosapent ethyl.9 The trial, Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT), aimed to evaluate the efficacy of icosapent ethyl in reducing cardiovascular events in patients with elevated triglyceride levels despite statin therapy. The results displayed that in patients who received 2 grams of icosapent ethyl twice daily, adverse cardiovascular events were significantly lower than patients receiving placebo.

Conclusion To conclude, the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/ APhA/ASPC/NLA/PCNA Cholesterol Guideline ushers in several shifts in the treatment of blood cholesterol when compared to the 2013 ACC/AHA guideline. The new guideline continues to focus on 4 treatment benefit groups and continues to support statin therapy as the foundational therapy for all cholesterol management regimens. However, the new guideline now includes recommendations for LDL-C targets and when to employ non-statin therapies within the treatment

benefit groups. The use of ezetimibe, PCSK9 inhibitors and bile acid sequestrants is supported by this guideline in addition to statin therapy in order to achieve LDL-C targets.1 The guideline also presents more comprehensive ways to assess patients’ risk through diabetes-specific risk enhancers, ASCVD risk enhancing factors, and CAC scoring. These tools allow for assistance in cases when treatment decisions are unclear and can help guide clinicians in selection of treatment.10,11 As the new 2018 guideline is implemented, new data will continue to be collected and published in order to further assist clinicians in their therapeutic decisions regarding treatment of blood cholesterol in their patients.

References 1. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ 2. ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol. Circulation.10 Nov 2018; https://doi.org/10.1161/CIR.0000000000000625 3. Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S1-S45.

4. Wilson PW, Polonsky TS, Miedema MD, et al. Systematic review for the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/N LA/PCNA guideline on the management of blood cholesterol: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018. doi:10.1016/j.jacc.2018.11.004 5. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2016 ACC expert consensus decision pathway on the role of non-statin therapies for LDLcholesterol lowering in the management of atherosclerotic cardiovascular disease risk: A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2016;68(1):92125. doi:https://doi.org/10.1016/j.jacc.2016.03.519 6. Lexicomp Online®, Lexi-Drugs®, Hudson, Ohio: Lexi-Comp, Inc.; March 4, 2019.

7. Cholestyramine [package insert]. Spring Valley, NY: Par Pharmaceutical Companies, Inc.; 2006 8. Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S76-99.

9. Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379(22):20972107.

10. Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.

11. New ACC/AHA cholesterol guideline allows for more personalized care; new treatment options. (2018, November 10). https://www.acc.org/latest-incardiology/articles/2018/11/07/15/19/sat-1130am-guideline-on-themanagement-of-blood-cholesterol. Accessed on March 4, 2019.

12. Was the juice worth the squeeze? Understanding the new 2018 AHA/ACC cholesterol guideline. (2018, November 15). https://www.acc.org/latest-in-cardiology/articles/2018/11/14/10/48/wasthe-juice-worth-the-squeeze. Accessed on March 4, 2019.

|29| www.KPHANET.org

April 2019 â&#x20AC;&#x201D; Update on the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Cholesterol Guideline 1. Which of the following is NOT one of the 4 treatment benefit groups as defined by the 2018 AHA/ACC/ AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ ASPC/NLA/ PCNA Cholesterol Guideline?

A. Diabetes Mellitus in Adults 40-75 Years of Age With LDL- C 70-189 mg/dL B. Primary Prevention based on ASCVD risk C. LDL-C >150 mg/dL D. Secondary ASCVD Prevention

7. A 45-year-old, male patient with a PMH of myocardial infarction, hypertension, and obesity presents with initial labs of triglycerides 180 mg/dL, LDL-C 90 mg/dL, HDL 30 mg/dL, and total cholesterol 190 mg/dL. In addition to lifestyle therapies, what is appropriate pharmacotherapy for this patient?

A. Rosuvastatin 40 mg B. Simvastatin 40 mg C. Lovastatin 40 mg D. Pravastatin 40 mg

2. What is the appropriate choice of treatment for a 64-yearold, male patient with diabetes, an LDL-C of 95 mg/dL, and no diabetic specific risk enhancers?

A. Atorvastatin 20 mg B. Simvastatin 20 mg C. Rosuvastatin 5 mg D. Rosuvastatin 20 mg

8. In recommending a low-cholesterol diet, what percentage of calories should come from saturated fats?

A. 20% B. 15% C. 10% D. 5%

3. Which of the following is NOT a diabetes-specific risk enhancer?

A. Rheumatoid arthritis B. Neuropathy C. Retinopathy D. eGFR <60 mL/min/1.73m2 4. In a 45-year-old, male patient falling in the primary prevention category with an LDL-C of 80 mg/dL and no history of diabetes, which of the following ASCVD risk percentages could lead to use of CAC scoring to help guide treatment decisions?

A. 1% B. 3% C. 12% D. 25%

9. Which of the following is NOT a common adverse effect seen in patients who take bile acid sequestrants?

A. Constipation B. Intestinal gas C. Dizziness D. Abdominal pain/cramping 10. Which of the following is the most common class of medication added on to statin therapy in the treatment of high blood cholesterol?

A. Ezetimibe B. Bile acid sequestrants C. Fibrates D. PCSK9 inhibitor

5. A 50-year-old, female patient with an LDL-C of 210 mg/ dL is started on atorvastatin 80 mg and is adherent to the medication for 3 months. LDL-C is now 180 mg/dL. What is appropriate to add on to statin therapy next?

A. Ezetimibe B. Fenofibrate C. Colesevelam D. Alirocumab 6 The same patient from question 5 returns with an LDL-C of 150 mg/dL. Of note, this patient also has heterozygous familial hypercholesterolemia. What would be appropriate to add on to this patientâ&#x20AC;&#x2122;s therapy?

A. Ezetimibe B. Alirocumab C. Colesevelam D. Fenofibrate

|30| Kentucky Pharmacists Association | March/April 2019

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Expiration Date: 3/28/2022 Successful Completion: Score of 80% will result in 1.0 contact hour or .10 CEUs. TECHNICIANS ANSWER SHEET April 2019 — Update on the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Cholesterol Guideline (1.0 contact hour) Universal Activity # 0143-0000-19-004-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

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Signature ____________________________________________Completion Date___________________________

PHARMACISTS ANSWER SHEET April 2019 — Update on the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Cholesterol Guideline (1.0 contact hour) Universal Activity # 0143-0000-19-004-H01-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. A B C D 10. A B C D

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

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Pharmacy Policy Issues Pharmacy Policy Issues: Can a Different Type of Collaborative Care Be an Asset to Addressing the Submit Questions: jfink@uky.edu Opioid Epidemic?

Author: : Eric M. Marr is a 2019 PharmD Candidate at the UK College of Pharmacy and an MBA Candidate in the Gatton College of Business and Economics at the University of Kentucky. A native of Glasgow, KY, he completed his pre-professional education at Western Kentucky University with a major in Chemistry.

Issue: There have been quite a few approaches and remedies suggested for the opioid crisis currently facing our state and country. Is there particularly innovative out there that has not attracted a great deal of attention but which might well have a beneficial effect?

one of the most trustworthy professions for decades, to help bridge this gap in public trust.

A study done by Jakubowski, et al. showed that people who were educated properly on their stateâ&#x20AC;&#x2122;s Good Samaritan laws were three times more likely to contact 911 in cases where they witnessed an overdose.2 This Discussion: For years now, the opioid epidemic has suggests that if a person knows how far the protection crippled families and economies across the nation.

Agreements have been made between healthcare practi- of the law reaches, he or she will be more likely to use it for its intended purposeâ&#x20AC;&#x201D;to prevent death from illicit tioners of all disciplines to do their respective part in treating the epidemic while holding a consensus that to drug use. Another study done by Tobin, et al. supports solve a problem of this magnitude it will take a commu- this theory. That study found that when participants witnessed an overdose, those who had prior exposure to nal effort. A type of collaboration that does not get as police were more likely to call emergency services for much attention, however, is collaboration between help. Conversely, those who did not have prior expohealthcare practitioners and members of law enforcesure to police were less likely to reach out. The reasonment. Is it time for pharmacists and their counterparts to start promoting collaborative care with criminal jus- ing proposed by this second study suggests that people who see police interaction with an overdose victim may tice more tenaciously so that the scales of justice and well conclude that the perception that arrest is a compublic health might begin to balance? mon outcome might be ill-informed, and the aversion to Good Samaritan laws are statutes enacted in 40 states calling 911 the next time would thus be lowered.3 and the District of Columbia to encourage the reporting The obvious issue that comes with this is that a person and response to individuals experiencing a drug over.1 dose These laws have the intention of promoting pub- needed to witness both an overdose as well as the police lic health and safety while the solution to the larger is- response to it before comprehending the goodwill resue of prescription and nonprescription opioid abuse is sponse. There is a prime opportunity for pharmacists to address this issue in a prophylactic manner. The recent still being scrutinized. Some states, like Vermont, are Board of Pharmacy authorization for a naloxone protovery cumbersome in their statute when an overdose is reported, granting immunity to all parties surrounding col allows Kentucky pharmacists to initiate the dispensing of the antidote to those who request it.4 The counan overdose victim.1 Other states like Nebraska have very strict Good Samaritan laws that only give immuni- seling session during the dispensing process would be ty to the person calling in the report of an overdose and an opportunity for pharmacists to prime individuals not the victim himself or herself.1 The efficacy of these with the notion that law enforcement is supporting the laws depends both on the language used in the underly- work that we do. Talking about the Good Samaritan ing statute and the trust people have in state and federal laws and having a conversation about what the intentions of police are in the situation can be as important government. Here lies an opportunity for pharmacy, |34| Kentucky Pharmacists Association | March/April 2019

as dispensing the drug itself.

In conclusion, in order to build trust in an area that has been lacking for decades, a strong relationship must be developed between pharmacies and local law enforcement personnel. Taking the concept of collaborative care into unconventional areas to creatively address issues could be a path forward in solving the opioid epidemic.

Reach out to your local sheriff or police department and develop a dialogue that communicates your shared goals. Together, pharmacy and law enforcement can use their combined resources to write a better treatment plan for our communities.

References: 1. http://www.ncsl.org/research/civil-andcriminal-justice/drug-overdose-immunity-goodsamaritan-laws.aspx#Calling%20911 2. Jakubowski A, Kunins HV, Huxley-Reicher Z, Siegler A. (2017) Knowledge of the 911 Good Sa-

maritan Law and 911-calling behavior of overdose witnesses, Substance Abuse, DOI: 10.1080/08897077.2017.1387213 3. Tobin KE, Davey MA, Latkin CA. (2005). Calling emergency medical services during drug overdose: An examination of individual, social and setting correlates. Addiction, 100(3), 397–404. https://doi.org/10.1111/j.1360-0443.2005.00975.x 4. K.R.S. 217.186 Pharmacy Law Brief Cont.

This is an order by the judge designed to go forward in time forever.

It is important to clarify a distinction related to use of the word “equity.” There is an accounting or financial context for the word, e.g., “How much equity do you have in your house?” That refers to the unencumbered value of the property over and above any mortgage obligation.

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Pharmacy Law Brief Achieving Justice – Law versus Equity Author: Joseph L. Fink III, BSPharm., JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy.

Disclaimer: The information in this column is intended for educational Question: As I’ve heard people talking over the years about resolving disputes through the court system I’ve heard references to both law and equity. People speak about those as if they were alternatives. What is the difference or distinction between the two?

Response: Law and equity are two separate approaches to achieving justice that have evolved over the centuries of our Anglo-American legal history. Historically there were separate courts having legal or ethical jurisdiction and authority. A piece of local history reflects this. If one were to visit the former Fayette County Courthouse on Main Street in Lexington prior to its renovation and look up at the windows above the doors to the courtrooms one would either see “Law Court” or “Equity Court” indicated there. Today courts are vested with both legal and equitable authority.

Equity evolved as an alternative approach to justice characterized by flexibility. Legal remedies are limited and rigid. Ethical remedies are more flexible and customizable to the individual situation. Some examples may serve to illustrate the distinction.

Suppose you have entered into a contractual relationship with someone who then refuses to perform the obligations under the agreement. You could bring a legal claim but the only thing you can collect is money damages attributable to the breach of contract. But if the case were filed and argued in equitable terms the court may have a number of other options available. One example is known as “specific performance.” This is where the court orders the party in breach of the contract to perform the obligations and commitments he or she made when entering into the agreement. This remedy is available in a number of situations such as: ● Contracts for the sale of real estate; ● Contracts for the sale of unique or irreplaceable goods; or ● Contracts in which the seller of a business agrees to

use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

a noncompetition clause.

Another remedy seen with the equitable authority of a court is issuance of an injunction. This is probably the equitable remedy that most people have heard about from various media outlets as it is used in labor disputes and other high profile controversies. An injunction is a court order directing that someone so something or stop doing something. Failure to comply with the edict of the court can result in a civil penalty such as paying a fine or even criminal penalties including imprisonment.

Typically, the individual failing to comply faces as contempt of court order.

There are several categories of equitable remedies under the broad designation of injunction. A Temporary Restraining Order (TRO) can, for example, be issued by a federal court for a period up to ten days. Interestingly, this court order can be initially imposed by the judge without a hearing and without informing to the party receiving the order (known as an ex parte proceeding).

A commonly seen example of this remedy is for claims of harassment, stalking or domestic violence.

The next level is a Preliminary Injunction. This approach does require advance notice to the affected party and the order typically remains in effect during the pending court case seeking to finally resolve the matter.

The goal of this remedy is to preserve the status quo while the court case is proceeding.

A Permanent Injunction is encountered as a final ruling in a case by the court following conclusion of the trial.

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Cont. pg. 35

Campus Corner Preceptor Highlight: Will Stewart, PharmD, BCPS. PGY1 Years of practice? How dence and efficacy. many of those years have Why did you choose to partner with the University of Kenyou precepted UK stutucky? What inspires you about the College of Pharmacy now dents? that you’ve been a preceptor for a while?

I have been in practice The UK College of Pharmacy has always offered strong for about nine years, preparation for experiential learning environments and a and have had students willingness to explore new training methods towards for six years. that end. It’s a pleasure to work with students who are What types of rotaengaged and interested in developing their patient care William Stewart and Dan Whitehouse, tions/courses do you skills, which are attitudes I believe the college fosters. current resident, from The Ohio State precept for?

APPE rotations are also a great way for us to get to University. know students who are interested in our residency proMy initial role as an gram.

APPE preceptor involved a cardiology learning experience. In 2018, I tran- What would you tell someone who is thinking about doing a rotation at your location? What should they expect? sitioned to precepting APPE students in an Advanced Hospital Practice experience, designed to give students a I would advise students interested in a rotation at Baptist more global understanding of inpatient and ambulatory Health Lexington that they should be prepared to help pharmacy services. Baptist Health Lexington also recenttake care of a broad patient population in a variety of ly began a partnership with the UK College of Pharmacy settings. Students will be exposed to everything from to precept Longitudinal Experiential Education in Phardistributional services to critical care to ambulatory care. macy (LEEP) program. We are excited to work with As with any rotation, the more engaged and the more these early learners while they identify their professional ownership displayed by the student, the more they will strengths and interests. gain from the experience. Early learners sometimes What do you like most about precepting students? “don’t know what they don’t know” and APPE rotations are the best place to fix that.

Taking part in the development and learning of a student pharmacist has always been a huge source of profession- How would you explain the role of the pharmacist in improving al satisfaction and a great way to give back to the profes- patient care? sion. I remember my transition from a classroom learnThe role of a pharmacist can vary widely depending on er to a student practitioner during my APPE year and the setting, which is part of what makes our profession how eye-opening my experiences were. Thanks to many so exciting. Pharmacists are uniquely trained to serve in excellent preceptors, I had the opportunity to ‘get my roles ranging from the distributional to the bedside, alhands dirty’ and better learn what it means to take care lowing almost endless opportunities to improve patient of patients. Being able to provide that kind of exposure outcomes. APPE experiences and residency training and feedback to APPE students and seeing them discovgive students the opportunity to develop a deeper underer new interests is what makes precepting so rewarding. standing of these roles and how their strengths might be Tell me about the area of pharmacy you’ve focused on in your best suited to them. career. What inspired you to pick this specific area of patient What advice would you give to students considering a residencare? cy?

I have been most heavily involved in cardiology and critI would advise students to choose challenging APPE ical care practice areas. Both areas deal with vulnerable patient populations and challenging complexity, which rotations and get out of their comfort zone as much as possible; this will go a long way towards helping them means that pharmacist interventions are critical. The need for patient education in both environments allows decide the type of culture and practice environment they for a great deal of patient interaction, as well. As these would like to take part in during residency training. I areas can be intimidating for students, it also makes for a would also suggest students keep an open mind about rewarding precepting environment as they develop confi|37| www.KPHANET.org

Campus Corner Preceptor Highlight: Faith Childress, Pharm D Featured Site: Walgreens can use that information to best Store #9005, 200 E. help our patients.

Broadway, Louisville, What do you love about being a preceptor?

Kentucky 40202 I am tremendously passionate about our ever growing Preceptor: Faith Chiland evolving field, and helping to truly develop those dress, PharmD, Universiwho are entering the field. I appreciate the opportunity ty of Findlay, Pharmacy to show students various aspects of community-based Manager, Residency Propharmacy and management beyond the dispensing porgram Coordinator, and tion. While I have not been in the field very long, I am Area 15 Immunization happy to be afforded the chance to share the knowledge Lead and expertise that I have gained throughout my career. I What unique opportunities feel an immense sense of pride when students get excitare available for a student on ed about the things they learn and are exposed to at my this rotation/site? site. I love nothing more than being able to speak with my previous APPE students after graduation and see As the immunization where they have ended up and continuing contact lead, HIV testing site coordinator and residency site cothroughout their career. ordinator for the area, students get the opportunity to see and help with each of those roles. As a preceptor for Highlights of the rotation/site: our PGY-1 Community Residency program, students During the rotation, students get the opportunity to get to work alongside the resident on a weekly basis. work in a high-volume, fast paced pharmacy while still This has allowed them to see first-hand the life of a resifocusing on the clinical aspects of community-based dent and utilize the resident as a resource if they are pharmacy. Students get a multi-faceted view at commuwanting to pursue a residency. In addition, our APPE nity-based pharmacy and management through daily, students get the opportunity to help precept the siteâ&#x20AC;&#x2122;s weekly and monthly activities, as well as weekly topic IPPE student. With guidance, they set-up weekly actividiscussions and top 200 brand-generic quizzes. Since ties for the IPPE student based on the IPPE checklist, our site is a center of excellence for HIV and compoundassist with weekly assignments, and help lead topic dising, students get to be focused more on the day-to-day cussions. Having multiple levels of learners all working and clinical activities of a community-based pharmacist in the same pharmacy is extremely beneficial as they are rather than strictly focusing on the dispensing role (i.e. able to share knowledge and experiences through the filling). phases of pharmacy school and residency.

What are some clinical services that are currently being offered?

As a company, we offer free blood pressure screenings, immunizations, in-depth patient counseling, specialty medications services through our local specialty site, and MTM services. In addition, at our site, we offer HIV medication management, compounding services, and free weekly HIV testing through a local partnership.

Students are able, and encouraged, to be a part of all the above services.

Where are you growing or expanding services/opportunities?

As a company, we recently have been able to view portions of days covered for patients on medications for diabetes, hypertension, and hyperlipidemia. At our location, we are looking to explore the ways in which we |38| Kentucky Pharmacists Association | March/April 2019

Feature Article Summer Camps for Children with Medical Conditions: A Service-Learning Opportunity for Students, Residents and Pharmacists Author: Emily O’Reilly, PharmD, PGY-2 Ambulatory Care Pharmacy Resident, University of Louisville Hospital Meeting new friends, sleeping in uncomfortable bunkbed cots, toasting marshmallows on a bonfire for s’mores, swimming, mosquito bites, playing capture the flag, friendship bracelets, the infamous food at the mess hall—ah, summer camp. For those that have attended, I’m sure these thoughts bring back some unforgettable sights and smells as well as memories of old friends. It is a wonderful experience for youth development and relationship building.

The American Camp Association reports that over 14 million children and adults in the United States attend camps annually. Benefits of camp reported by campers and parents include making new friends, trying new experiences, gaining self-confidence, connecting with peers from different backgrounds and more.1 However, many of these camps are not equipped for children with various medical conditions. As such, organizations have developed camps specifically to provide a safe environment for children with chronic conditions to experience the fun of camp like any other kid. To provide a quality experience for these children, camps rely on medical staff volunteers, including pharmacists.

Pharmacists, Residents and Students Volunteering at Camp Pharmacists and learners alike can serve as valuable volunteers at various camps for children with medical conditions by providing their expertise on medication management. Furthermore, they can serve as an extension of other health care providers to increase the quality of patient care. For student learners completing advanced pharmacy practice experiences (APPEs), literature describes disease state camps, specifically diabetes and asthma, being incorporated into the following rotations: ambulatory care, pediatrics elective, or other elective.2-4 Additionally, early experiential students have been involved in such camps for introductory pharmacy practice experience (IPPE) requirements.5 These camps provide a robust service-learning experience for students, as they allow for clinical application to a population in need, especially when students create goals prior to attending camps and complete structured re-

flection. Benefits of student pharmacists participating in such camps include gaining empathy by “living the life of patients with the disease,” increasing clinical confidence, developing commitment to service and collaborating with other healthcare professionals.2-5 Lastly, participation by students and precepting pharmacists, primarily faculty members, increases visibility of the profession.4 Similarly, pharmacy residents can also develop their patient care skills by serving as volunteers at disease state focused camps.6 A group of PGY-2 ambulatory care pharmacy residents noted that they received training related to diabetic supplies, including various insulin pumps and continuous glucose monitors (CGMs), prior to attending a diabetes camp. While at camp, they applied this newly developed skill set with pediatric patients, which greatly enhanced their aptitude for caring for patients with type 1 diabetes mellitus (T1DM).

The residents reflected on their professional growth and personal reward from camp, specifically with regards to empathy and empowering pediatric patients to begin to care for their own disease state. Their program had participated in this camp for multiple years, which allowed them to expand their role in patient care by demonstrating their value to the medical staff at camp.6 My Experience at Camp Korelitz Similarly, I served as a medical staff member for the American Diabetes Association (ADA) Camp Korelitz located in Clarksville, OH, for a learning experience for my PGY-2 ambulatory care pharmacy residency. As a pharmacist, I was paired with a pediatric endocrinologist to help manage the group of 14-year-old boys. As my preceptor for the week, the pediatric endocrinologist modeled for me how to complete pre-meal blood glucose checks, adjust insulin and carbohydrate ratios on meal cards and organize my blood glucose log tracker on the first day. Thereafter, she served as a facilitator, allowing me to make clinical decisions for my campers with her available to answer questions as needed.

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My most impactful patient care experience was managing my campers blood glucose levels, especially hyperglycemia. Unfortunately, I had two campers experience diabetic ketoacidosis (DKA) due to their subcutaneous insulin pump sites malfunctioning overnight, which was realized at 7:00am blood glucose checks. They both experienced the tell-tale signs and symptoms of DKA: vomiting, blood glucose in the 500s and large ketones in the urine when testing with Ketostix® reagent strips. Neither camper was wearing their CGM at camp, demonstrating the risk of utilizing an insulin pump without a CGM programmed with out of range alerts. These situations showed me how quickly a patient with T1DM can enter into a state of DKA, as both had blood glucose readings in normal range at the 3:00am blood glucose checks. Even more amazing, due to the care from myself, the pediatric endocrinologist and the nurses at the medical cabin, both boys were able to return to regular camp activities in about four hours after receiving subcutaneous insulin injection and IV fluids.

first-time attendees to this camp, but I quickly felt welcomed and appreciated for my time and willingness to learn the “Korelitz-way.”

The reason I am describing this family-like culture is to give a sense of how special this camp truly is for those that attend. Just being part of this culture was the most impactful non-patient care experience. From this community I saw first-hand how vital social support is for those managing chronic disease states, and how it is necessary to not only learn from medical professionals, but also from peers. One of my campers told me, “It is so much easier to manage my diabetes at camp.” When I asked him why he thought that was, he responded, “Because I have more support here and do not feel like an outcast for having to take a break when I go low.” All of my campers benefited from a week of camaraderie, as they shared similar challenges of diabetes management. Camp allowed them to “just be kids” and have fun. From this experience, I have begun recommending patients and friends to participate in camps and/or social I also shared the experience of frustration when their groups that allow for learning about their disease blood glucose did not respond as anticipated, as I was state from peers. directly responsible for their numbers based on how I adjusted their regimen. They told me that this is one As for the requirements of this learning experience of the annoying parts of diabetes – “you can eat the for my residency training, I submitted a reflection to same amount of carbs and dose the same amount of my residency program director. Reflection is necesinsulin from one day to the next, but your body’s sug- sary following volunteering at such a camp for proar won’t react the same way because so many other fessional growth and development. Specifically, my things can impact it. Sometimes there is an explana- reflection was tied to the following American Society tion for when your sugar is out of range, but someof Health-System Pharmacists (ASHP) learning obtimes there is not. You just correct it and keeping try- jectives for ambulatory care: ing to stay within goal the best you can.” While I  R1.1.1: (Applying): Interact effectively with have educated patients countless times on the imhealth care teams to collaboratively manage amportance of self-monitoring blood glucose, even if it bulatory care patients’ medication therapy. is a time-consuming task, I did not fully understand  R1.1.2 (Applying): Interact effectively with amthe demands of this recommendation until assisting bulatory care patients, family members, and carewith blood glucose checks 24/7 while at camp. givers.  R1.1.8 (Applying): Demonstrate responsibility to Even more rewarding than the clinical knowledge ambulatory care patients for patient outcomes. and skills gained was the immersion in camp culture I highly recommended my residency program direcand relationships formed with my campers, counse- tor to maintain this learning experience, as the skills lors and other medical staff. Many of the campers and experiences gained cannot be attained in day-toattended every year since diagnosis and formed last- day clinic experiences. Furthermore, I think other resing friendships as they “grew up together” through idency programs should consider the addition of such camp since their activities were arranged by age. a learning experience if it is not already part of their Campers were ages 8-15, but their time at Camp Ko- core rotations. relitz did not stop there as they could continue to attend camp as junior counselors (age 16-17), senior Camps in Kentucky and Surrounding States counselors (age 18 and older) and unit leaders (after There are many opportunities for learners and pharat least two years of serving as a senior counselor). macists to volunteer as medical staff for disease state This model allowed for peer support and ability to focused camps within Kentucky and surrounding gain leadership skills. Many of the medical staff have states. Refer to Table 1 for various opportunities served for more than 15 years; two physicians were (note: this is not an all-inclusive list). I encourage all former campers themselves. I was one of the rare, |40| Kentucky Pharmacists Association | March/April 2019

pharmacists to identify a camp that aligns with their passion and consider volunteering as medical staff for at least one summer. The impact such an experience can have on your interpersonal and clinical skills is invaluable.

http://www.happyhollowcamp.net/overnight-camps/#asthmacamp-sec (accessed Jan 15, 2019).

Center for Courageous Kids. Camp Schedule. https://www.courageouskids.org/apply-to-cck/camp-schedule/ (accessed Jan 15, 2019).

Camp Joy. Specialty Camps. https://campjoy.org/camps/specialty-camps/ (accessed Jan 15, 2019).

American Diabetes Association. Camp Sugar Falls.

References https://engage.active.com/landing_page/camp_sugarfalls_2017 American Camp Association. ACA facts and trends. https://www.acacamps.org/press-room/aca-facts-trends (accessed (accessed Jan 15, 2019).

American Diabetes Association. Camp Korelitz.

Dec 27, 2018). www.diabetes.org/adacampkorelitz (accessed Jan 15, 2019).

Johnson JF. A diabetes camp as the service-learning capstone Camp Hendon. 2019 Summer Camp. experience in a diabetes concentration. Am J Pharm Educ. https://www.camphendon.org/register-for-camp.html (accessed 2007;71:1-8.

Kirwin JL, Van Amburgh JA and Napoli KM. Service-learning at Jan 15, 2019). a camp for children with asthma as part of an advanced pharmacy Kids Cancer Alliance. Events Calendar. https://kidscanceralliance.org/events/calendar/ (accessed Jan 15, practice experience. Am J Pharm Educ. 2005;69:321-329.

Condren M. Diabetes camp as an experiential clerkship site. Am 2019).

Lions Camp Crescendo. Camp Heart to Heart.

J Pharm Educ. 2003; 67:1-6. http://www.lccky.org/our%20camps.htm (accessed Jan 15, 2019).

Johnson JL, Carwford LD, LaRochelle JM. A summer diabetes camp as an interprofessional service-learning experience for early experiential pharmacy students. Curr Pharm Teach Learn.

Abbreviations: ADA = American Diabetes Associa2014;6:494-501. tion; CCK = Center for Courageous Kids; KCA = Evoy KE, Raber HP, Battjes EN, et al. Volunteering as medical Kids Cancer Alliance; TBD = to be determined staff at a diabetes summer camp as a component of a pharmacy residency program.

Happy Hollow Childrenâ&#x20AC;&#x2122;s Camp. Asthma Camp.

Camp

Table 1. Disease State Camps in Kentucky and Surrounding States

Location

Dates

Asthma Asthma Camp at Happy Hollow7 Camp SuperBreathers9

Nashville, IN Clarksville, OH

June 23-28, 2019 June 14-16, 2019

CCK: Asthma and Siblings8

Scottsville, KY

June 29-July 3, 2019

Congenital Heart Disease Camp Joyful Heart9

Clarksville, OH

CCK: Brave Hearts and Siblings8

Scottsville, KY

May 17-19, 2019 & June 23-28, 2019 July 7-11, 2019

Antioch, TN

June 17-21, 2019

Diabetes ADA: Camp Sugar Falls10 ADA: Camp Korelitz

11

Clarksville, OH

July 27-August 3, 2019

Camp Hendon

12

Leitchfield, KY

June 30-July 5, 2019

Camp Hendon

12

Ravenna, KY

July 14-19, 2019

8

Scottsville, KY

June 2-6, 2019

Scottsville, KY

July 14-18, 2019

Camp NJoyItAll Teen Week9

Clarksville, OH

July 14-19, 2019

Camp NJoyItAll Youth Week CCK: Hematology/Oncology/ Immune Disorders8 KCA: Indian Summer Younger Oncology Camp13 KCA: Indian Summer Older Oncology Camp13 HIV/AIDS

Clarksville, OH

July 21-26, 2019

Scottsville, KY

June 9-13, 2019

Perryville, KY

June 9-15, 2019 & June 23-29, 2019

Perryville, KY

July 7-13, 2019

Camp Heart to Heart14

Lebanon Junction, KY

July 8-12, 2019

CCK: Diabetes Epilepsy

CCK: Epilepsy and Siblings8 Hematology/Oncology

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|42| Kentucky Pharmacists Association | March/April 2019

|43| www.KPHANET.org

2018—2019 KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES Tyler Stephens, Lexington Speaker of the House stevens.tyler@uky.edu

Chris Harlow, Louisville cpharlow@gmail.com

Chair

Chris Palutis, Lexington chris@candcrx.com

President

Don Kupper, Louisville donku.ulh@gmail.com

President-Elect

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Bob Oakley, Louisville rsoakley21@gmail.com

Chair

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Secretary

Joel Thornbury, Pikeville jthorn6@gmail.com

Past President Representative

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Chris Palutis, Lexington chris@candcrx.com

President, KPhA

Directors Angela Brunemann, Union Angbrunie@gmail.com

KPERF BOARD OF DIRECTORS

Kimberly Croley, Corbin kscroley@yahoo.com

Matt Carrico, Louisville* matt@boonevilledrugs.com

Kevin Lamping, Lexington klamping@riteaid.com

Jessika Chilton—Chinn, Beaver Dam jessikachilton@ymail.com Dharti Patel, Lexington dharti.patel2@uky.edu

Ben Mudd, Lebanon Vice Speaker of the House bpmu222@gmail.com

University of Kentucky Student Representative

Paul Easley, Louisville rpeasley@bellsouth.net Sarah Lawrence, Louisville slawrence@sullivan.edu

Chad Corum, Manchester pharmdky21@gmail.com

KPERF ADVISORY COUNCIL

Cassy Hobbs, Louisville cbeyerle01@gmail.com Stephen Drog, Louisville sdrog5833@my.sullivan.edu

Sullivan University Student Representative

Chris Killmeier, Louisville cdkillmeier@hotmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com James "Blake" Wiseman, Benton blake.wiseman@gmail.com *At-Large Member to Executive Committee

Matt Carrico, Louisville matt@boonevilledrugs.com Kim Croley, Corbin kscroley@yahoo.com Kimberly Daugherty, Louisville kdaugherty@sullivan.edu Mary Thacker, Louisville mary.thacker@att.net

KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd., Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) info@kphanet.org www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc

|44| Kentucky Pharmacists Association | March/April 2019

“The American Pharmaceutical Association (APhA) and the National Association fo Retail Druggists (NARD) have agreed to coordinate their legislative efforts in support of S. 1575, introduced March 17, 1969 by Senator Philip A. Hart (D-Mich.). S. 1575 seeks to curb physician dispensing, ownership of pharmacies and profiteering on drugs.”

- From The Kentucky Pharmacist, April 1969, Volume XXXII, Number 4

Frequently Called and Contacted Kentucky Pharmacists Association 96 C Michael Davenport Blvd.

Frankfort, KY 40601 (502) 227-2303 info@kphanet.org www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org

National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center SUCOPHS 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

KPhA Staff Mark Glasper Executive Director mglasper@kphanet.org Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org

Michele Pinkston, PharmD, BCGP Director of Emergency Preparedness Michele@kphanet.org Sydney Hull Office Assistant/Member Services Coordinator shull@kphanet.org

Angela Gibson Director of Finance & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Public Health jjaggers@kphanet.org Jessica Johnson, PharmD Director of Pharmacy Education Jessica@kphanet.org |45| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601